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48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Had TAVI procedure in UK Nil | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Aortic Valve Insufficiency Transcatheter Aortic Valve Replacement Patients in whom transcatheter aortic valve implantation is attempted at participating center None except failure to obtain informed consent | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Cystic Fibrosis Confirmed diagnosis of CF Forced expiratory volume in 1 second (FEV1) 40-90% predicted Non-smoker and non-tobacco user for a minimum of 30 days prior to screening and for the duration of the study Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1 History of cancer within the past five years (excluding cervical CIS with curative therapy for at least one year prior to screening and non-melanoma skin cancer) History of organ transplantation Any sinopulmonary infection or CF exacerbation requiring a change or addition of medication (including antibiotics) within 1 month of Study Day 1 or any other clinically significant infection as determined by the investigator within 1 month of Day 1 History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator Male and female of child-bearing potential, unless they are using highly effective methods of contraception during participation in the clinical study and for 4 weeks after termination from study Pregnant or nursing women | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Dysphagia Dysphonia Postoperative Pain Patients > 18 years of age 2. Primary two and three-level ACDF between C3-7 3. Approved pre-authorization to undergo the procedure Patients < 18 years of age 2. Patients who are unable to give their own consent 3. Revision ACDF 4. Combined anterior-posterior surgeries 5. Surgeries involving C2-C3 or C7-T1 6. Surgeries related to trauma, infection, or tumor 7. Patients with baseline swallowing dysfunction 8. Patients currently on steroids 9. Patients with severe cardiac disease 10. Uncontrolled diabetics as defined by patients with a HbA1C > 8% 11. Patients with known allergy to epinephrine | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Patient with severe degenerative native aortic stenosis (AS) Patient at high risk for open surgical valve replacement Patient symptomatic according to NYHA functional class II or higher Congenital uni or bicuspid aortic valve morphology Previous prosthetic aortic valve (bioprosthesis or mechanical) implant Endocarditis or other active infection Need for urgent or emergent TAVR procedure for any reason Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortic Valve Stenosis Severe aortic stenosis, defined as aortic valve area of <1.0 cm2 (or aortic valve area index of <0.6 cm2/m2) by the continuity equation, AND mean gradient >40 mmHg OR maximal aortic valve velocity >4.0 m/sec by resting echocardiogram 2. Society of Thoracic Surgeons(STS) score of ≥8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities 3. Symptoms of aortic stenosis AND New York Heart Association (NYHA) Functional Class II or greater 4. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve) 2. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre medicated aspirin or heparin (HIT/HITTS) and bivalirudin ticlopidine and clopidogrel nitinol (titanium or nickel) contrast media 3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states 4. Untreated clinically significant coronary artery disease requiring revascularization 5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography 6. End stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min. 7. Ongoing sepsis, including active endocarditis 8. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure 9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment 10. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support 11. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 12. Gastrointestinal (GI) bleeding that would preclude anticoagulation 13. Subject refuses a blood transfusion 14. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) 15. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions 16. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams 17. Currently participating in an investigational drug or another device study (excluding registries) 18. Evidence of an acute myocardial infarction ≤30 days before the study procedure 19. Need for emergency surgery for any reason 20. Liver failure (Child-Pugh class C) 21. Subject is pregnant or breast feeding 22. Pre existing prosthetic heart valve in any position 23. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation) 24. Severe mitral regurgitation 25. Severe tricuspid regurgitation 26. Moderate or severe mitral stenosis 27. Hypertrophic obstructive cardiomyopathy 28. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation 29. Congenital bicuspid or unicuspid valve verified by echocardiography 30. Access vessel diameter <5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA) | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Valve Heart Diseases All consecutive patients referred for organic MR and/or AR at least moderate to severe according to the ESC guidelines criteria⁴ will be eligible. The moderate to severe will defined by echocardiography as followed MR: an effective regurgitant orifice area (EOA) >30mm2 and/or a regurgitant volume (RV) >45mL AR: an EOA >20mm2 and/or a RV >45mL Age < 18 years Pregnancy Impossibility to maintain a decubitus position Arrhythmia that do not allow an ECG synchronization during MRI Hemodynamic instability Indication of urgent surgery Known coronary artery disease Severe arterial hypertension Cardiomyopathy Claustrophobia | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 50.0-85.0, Heart Valve Diseases Coronary Artery Disease Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass which is expected to last up to 6 hours. 2. Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG). 3. The patient is >50 and <85 years of age. 4. The patient's body weight is compatible with blood net flow of 4 [l/min]. 5. Patient with left ventricular ejection fraction >30% as assessed by either echocardiography, angiography or by radio nuclear assessment (MUGA) 6. The patient is willing to participate as evidenced by signing the written informed consent. 7. Male or non-pregnant female patient (Note: Females of child bearing potential must have a negative pregnancy test) Patient with abnormal clotting mechanism: PT 60%, PTT>2 the normal. 2. Patient with an aortic trauma. 3. Patient contraindicated for open heart surgery under bypass machine. 4. Patient undergoing a re-do procedure. 5. Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy) 6. Patient with pathologies which affect his/her neurological condition. 7. Patient in whom emergency operation is required. 8. Patient with a known allergy to Heparin 9. Patient with major co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study, including but not limited to previous stroke critical preoperative state poor ventricular function severe pulmonary hypertension [19] Atheroembolism history of cardiac failure [20] 10. Current use of drugs that might result in high surgical risk or significant postoperative complication. 11. Psychological instability, inappropriate attitude or motivation. 12. Patients with life threatening debilitating disease other than cardiac. 13. Subjects currently enrolled in another investigational device or drug trial that has not completed the primary end point or that clinically interferes with the current study endpoints | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Acute Kidney Injury Renal Insufficiency, Chronic Heart Failure Myocardial Infarction Arrhythmias, Cardiac Stroke Subjects are eligible to participate if they are undergoing TAVR for aortic stenosis at the University of Texas Southwestern Medical Center The patient cannot or will not provide informed consent. 2. The patient is aged less than 18 years. 3. The patient's pre-procedural hematocrit is less than 25%. 4. The patient has known hepatitis C and/or human immunodeficiency virus infection 5. In the opinion of the principal investigator, the patient will be unlikely to complete long-term follow up for medical or social reasons | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Severe and Symptomatic Aortic Stenosis Stable Coronary Disease Patients older than 18 years Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision Recent acute coronary syndrome (within 30 days before randomization) Unprotected left main disease Critical stenosis (>90%) of Left Anterior Descending artery (LAD) Significant angina (CCS class more than 2) Active bleeding Contraindication for tomographic technetium-99 assessment or dipyridamole injection Previous enrollment in a other study Impossibly to obtain consent | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 70.0-999.0, Aortic Valve Stenosis 70 years of age or older 2. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec 3. Symptomatology due to aortic stenosis resulting in one of the following: 1. NYHA Functional Classification of II or greater 2. Presence of angina 3. Presence of syncope 4. Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter 5. STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities. 6. Geographically available, willing to comply with follow up and able to provide written informed consent Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success. 2. Patients at high risk for coronary obstruction in the opinion of the investigator (e.g. combination of a coronary height < 12 mm and coronary sinus diameter < 30 mm) 3. Patients with low flow/low gradient aortic stenosis 4. Patients with significant annular calcification (e.g. Agatston score > 4000) 5. Pre-existing prosthetic heart valve in any position, or prosthetic ring 6. Severe aortic, mitral or tricuspid valve regurgitation 7. Moderate to severe mitral stenosis 8. Myocardial infarction within the past 30 days* 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation 10. LVEF < 30% 11. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure 12. Hemodynamic instability requiring inotropic drug therapy within the past 14 days 13. Untreated clinically significant coronary artery disease requiring revascularization 14. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery 15. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy 16. Patient ineligible for or refuses blood transfusions 17. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or vessels < 6 mm) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT 18. Active peptic ulcer or gastrointestinal bleeding within the past 90 days* 19. Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic attack) within past 6 month, or treatment of carotid stenosis within past two months* 20. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis 21. Active infection requiring ongoing treatment 22. Need for emergent surgery or intervention other than the investigational procedure 23. Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure, except for PCI which is within 7 days of the index procedure* 24. Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated 25. Life expectancy < 1 year due to non-cardiac co-morbid conditions 26. Currently participating in any investigational drug or device studies that may confound the results of this study 27. History of any cognitive or mental health status that would interfere with study participation 28. Following surgical consultation, patient is deemed inoperable in the event that surgical intervention is required after HLT valve implantation attempt At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Disease Age 18 or greater Patients with known BAV diagnosed by echocardiography, previous MRI, or cardiac CT Scheduled for cardiac MRI or have had a cardiac MRI within the past year Able to provide informed consent Ambulatory and expected to be able to complete 6 minute walk test Patients without BAV Patients who have already had surgery for aortic valve problems and/or aortopathy Unable to complete 6 minute walk test (ex. Wheelchair bound) | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 22.0-999.0, Mitral Annular Calcification Subject has severe native mitral annular calcification associated with mitral stenosis and/or regurgitation. Qualifying echo must be within 60 days of the date of the procedure Subject has a clinical indication for mitral valve replacement, as demonstrated by reported New York Heart Association (NYHA) Functional Class II or greater The subject is at least 22 years old The Heart Team agrees that the subject is high risk or inoperable for surgical mitral valve repair or replacement (MVR), based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The following concomitant procedures, are allowed: MAZE, Tricuspid Valve Procedures (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and septal myectomy The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site The study subject agrees to comply with all required post-procedure follow-up visits Evidence of an acute myocardial infarction (MI) ≤ 30 days before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)] Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease) Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8 g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL) Hemodynamic or respiratory instability requiring vasoactive medications, mechanical ventilation at time of procedure Need for emergency surgery for any reason Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) < 30% Severe right ventricular dysfunction Pregnancy, lactation, or planning to become pregnant Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active infective endocarditis Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without treatment or 30 days prior to procedure with definitive treatment | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Stenosis Group 1 : non aortic stenosis Goup 2, 3 and 4 : aortic stenosis | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Acute Kidney Injury Provide written informed consent 2. Age ≥ 18 years of age 3. Elective cardiac or aortic surgery with CPB>90 minutes 4. Stable pre-operative renal function without evidence of plasma creatinine level increase of ≥ 0.3 mg/dL over the prior 3 months and without renal replacement therapy (RRT). 5. Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire eGFR less than 30 ml/min/1.73 m2 2. Emergent cardiac surgery. 3. Life expectancy < 1 year at the time of enrollment. 4. Hemodynamic instability as defined by a systolic blood pressure <90 mmHg. 5. Mean pulmonary artery pressure ≥ 40 mm Hg and PVR > 4 Wood Units. 6. Left ventricular ejection fraction < 30% by echocardiography obtained within three months of enrollment 7. Administration of one or more Packed Red Blood Cells (RBCs) transfusion in the week prior to enrollment. 8. X-ray contrast infusion less than 48 hours before surgery. 9. Evidence of intravascular or extravascular hemolysis from any other origin: i. Intravascular: Intrinsic RBCs defects leading to hemolytic anemia (eg, enzyme deficiencies, hemoglobinopathies, membrane defects). Extrinsic: liver disease, hypersplenism, infections (eg, bartonella, babesia, malaria), treatment with oxidizing exogenous agents (eg, dapsone, nitrites, aniline dyes), exposure to other hemolytic agents (eg, lead, snake and spider bites), lymphocyte leukemia, autoimmune hemolytic disorders. ii. Extravascular: Infection (eg, clostridial sepsis, severe malaria), paroxysmal cold hemoglobinuria, cold agglutinin disease, paroxysmal nocturnal hemoglobinuria, iv infusion of Rho(D) immune globulin, iv infusion of hypotonic solutions | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 70.0-999.0, Aortic Valve Stenosis 70 years of age or older 2. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec 3. Symptomatology due to aortic stenosis resulting in one of the following: 1. NYHA Functional Classification of II or greater 2. Presence of angina 3. Presence of syncope 4. Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter 5. STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities. 6. Geographically available, willing to comply with follow up and able to provide written informed consent Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success. 2. Patients at high risk for coronary obstruction in the opinion of the investigator (e.g. combination of a coronary height < 12 mm and coronary sinus diameter < 30 mm) 3. Patients with low flow/low gradient aortic stenosis 4. Patients with significant annular calcification (e.g. Agatston score > 4000) 5. Pre-existing prosthetic heart valve in any position, or prosthetic ring 6. Severe aortic, mitral or tricuspid valve regurgitation 7. Moderate to severe mitral stenosis 8. Myocardial infarction within the past 30 days* 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation 10. LVEF < 30% 11. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure 12. Hemodynamic instability requiring inotropic drug therapy within the past 14 days 13. Untreated clinically significant coronary artery disease requiring revascularization 14. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery 15. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy 16. Patient ineligible for or refuses blood transfusions 17. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or vessels < 6 mm) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT 18. Active peptic ulcer or gastrointestinal bleeding within the past 90 days* 19. Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic attack) within past 6 month, or treatment of carotid stenosis within past two months* 20. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis 21. Active infection requiring ongoing treatment 22. Need for emergent surgery or intervention other than the investigational procedure 23. Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure except for PCI which is within 7 days of the index procedure* 24. Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated 25. Life expectancy < 1 year due to non-cardiac co-morbid conditions 26. Currently participating in any investigational drug or device studies that may confound the results of this study 27. History of any cognitive or mental health status that would interfere with study participation * At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Cardiomyopathy, Hypertrophic Cardiomyopathy, Hypertrophic, Familial Key Hypertrophic cardiomyopathy with symptoms of moderate-to-severe heart failure Left ventricular hypertrophy with maximum LV wall thickness ≥ 15 mm Left ventricular ejection fraction ≥ 50% Able to perform exercise testing but unable to exceed 75% of the predicted age-adjusted maximum level Key CYP2D6 Poor Metabolizer (PM) status History of a known chronic liver disease ALT, AST, alkaline phosphatase, or LDH > 1.5 x upper limit of normal Total Bilirubin > 2.0 x upper limit of normal Severe LV outflow obstruction Asymptomatic patients or cardiomyopathy-related as per protocol QT interval related as per protocol | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Congestive Heart Failure Heart Failure, Left-Sided Left-Sided Heart Failure Heart Failure with Preserved Ejection Fraction (HFpEF) Normal left ventricular ejection fraction (≥50%) Elevated Left Ventricular filling pressures at cardiac catheterization (defined as resting Pulmonary Capillary Wedge Pressure>15 mmHg and/or ≥25 mmHg during exercise) Prior albuterol therapy (within previous 48 hours) Current long acting inhaled beta agonist use Significant hypokalemia (<3meq/L) Significant valvular disease (>moderate left-sided regurgitation, >mild stenosis) High output heart failure Severe pulmonary disease Unstable coronary disease Constrictive pericarditis Restrictive cardiomyopathy Hypertrophic cardiomyopathy | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Bicuspid Aortic Valve bicuspid aortic valve, confirmed by transthoracic or transesophageal echocardiography With or without an aneurysm of the ascending thoracic aorta nonsyndromic aortic syndromic pathology antecedent of acute articular rhumatism | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Disorder Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe) 2. No indication for the surgical treatment at the time of enrolment 3. LV EF ≥ 50 % 4. Absence of more than mild concomitant valve disease or complex congenital heart disease Age < 18 years 2. Clearance Creatinine < 30 mL/min 3. Contraindication of magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, aneurysm clip, metallic fragment in the eye or near sensitive tissue) 4. Pregnancy | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Bicuspid Aortic Valve known bicuspid aortic valve calcified mild to moderate aortic valve stenosis on prior echocardiography informed consent provided absence of calcified aortic valve stenosis on echocardiography presence of severe aortic valve stenosis history of aortic valve repair or replacement accepted atrial fibrillation use of oral anticoagulants claustrophobia presence of a pacemaker, ICD or ferromagnetic materials in the body life expectancy <2 years Pregnancy (current or wish for near future) soy allergy | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Pain Hernia MUST HAVE TO Inclusion/ Active Duty members and DoD beneficiary patient 18 years or older Elective, open unilateral inguinal herniorrhaphy using Lichtenstein (tension free with mesh) hernia repair technique Agree to take only the prescribed oral analgesic medication (oxycodone/acetaminophen), plus or minus ibuprofen, for the initial fourteen-day post-operative period, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued.Agree to honestly complete a depression screening questionnaire, illicit drug use personal history and questionnaire, and physical activity assessment questionnaire, with the knowledge that if the patient is an active duty member, this information could result in a referral to medical or command authorities for potential Uniform Code of Military Justice (UCMJ) violations or concerns for subject health and fitness for duty Subjects who are pregnant or nursing Patients who refuse to complete the illicit drug use, physical activity, and depression questionnaires Strangulated, incarcerated, or otherwise emergent, urgent, and non-elective inguinal herniorrhaphy Those patients who are allergic to, refuse to take, or are otherwise unable to take oxycodone, ibuprofen, or acetaminophen medication orally for post-operative pain management Patients on pain contracts, or under the care of a pain medicine specialist for management of chronic pain at the time of surgery Subjects with serum creatinine level > 1.3 mg/dL as measured at the baseline study visit Subjects with serum aspartate transaminase (AST) greater than 3 times the upper limit of normal (level >102 U/L) Subjects with serum alanine transaminase (ALT) greater than 3 times the upper limit of normal (level > 165 U/L) | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Heart Disease Age > 18 Patient who underwent a transcatheter aortic valve implantation Patient who provided informed, written consent to participate to TAVI study Patient for whom a CT-Scan performed before TAVI procedure is available none | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Ischemic Heart Disease Stable ischemic heart disease and previous percutaneous coronary intervention (PCI Under optimal medical treatment including aspirin and cholesterol lowering drugs (statins) PCI treatment during the last 30 days Inability to provide informed consent Already following a vegetarian or a vegan diet Known vitamin B deficiency Known food allergy Previous obesity surgery or gastric bypass surgery Life expectancy <1 year | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Stenosis Subject must be at least 18 years old 2. Severe aortic stenosis defined as Mean aortic gradient > 40 mmHg or Peak jet velocity > 4.0 m/s or Aortic valve area of < 0.8 cm2 3. High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum 4. NYHA Functional Class > II 5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions porcelain aorta or severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or vessels too small for retrograde approach or other anatomical conditions making transapical approach more suitable 6. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE 7. Patient willing to participate in the study and provides signed informed consent Congenital unicuspid or bicuspid aortic valve or non-calcified 2. Extreme eccentricity of calcification 3. Severe mitral regurgitation (> Grade 3) 4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring 5. LV apex is not accessible via transapical access due to severe chest deformity 6. Previous surgery of the LV using a patch, such as the Dor procedure 7. Presence of apical LV thrombus 8. Calcified pericardium 9. Septal hypertrophy unacceptable for transapical procedure 10. Transesophageal echocardiogram (TEE) is contraindicated 11. ECHO evidence of intracardiac mass, thrombus, or vegetation 12. LVEF < 20% by ECHO 13. Need for emergency intervention for any reason within 30 Days of scheduled procedure 14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure 15. Untreated clinically significant coronary artery disease requiring revascularization within 30 days before or after the study procedure 16. Acute myocardial infarction within 1 month prior to implant procedure 17. Previous TIA or stroke within 6 months prior to implant procedure 18. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure 19. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit 20. History of bleeding diathesis, coagulopathy, refusal of blood transfusions or severe anemia (Hb<8 g/dL) 21. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP 22. Primary hypertrophic obstructive cardiomyopathy (HOCM) 23. Active infection or endocarditis 24. Hepatic failure (> Child B) 25. Chronic renal dysfunction with serum creatinine > 3.0 mg/dL or renal dialysis 26. Neurological disease severely affecting ambulation, daily functioning, or dementia 27. Life expectancy < 12 months due to non-cardiac co-morbid conditions 28. Intolerance to aspirin, clopidogrel, contrast media, or porcine tissue and allergy to nickel 29. Pregnant or breast-feeding women 30. For other severe illnesses of the patient (e.g. active carcinoma), the investigator shall decide on an individual basis whether the patient is not to be included in the study 31. Currently participating in an investigational drug or another device study | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Severe Symptomatic Aortic Stenosis Stable patients with severe symptomatic aortic stenosis Patient undergoing planned TF-TAVI with the prosthesis TF-TAVI using a minimalist approach of local anesthesia and conscious sedation The use of other (than Edwards or XT) transcatheter aortic valve devices TF-TAVI requiring general anesthesia or surgical cut-down TF-TAVI performed in unstable patients or on an urgent/emergent basis Non-transfemoral routes of valve delivery (eg. transapical, transaortic, etc) Discharge back home impossible (including transfer in another hospital) Programmed transfer to another hospital | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-100.0, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc" | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-80.0, Heterozygous Familial Hypercholesterolemia Men or women with heterozygous FH aged between 18 and 80 years FH patient carrying a documented mutation in the LDL receptor gene Subjects must be willing to give written informed consent and able to adhere to visit schedule Men or women < 18 or > 80 years Non-FH subjects History of alcohol or drug abuse within the past 2 years Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Severe Aortic Stenosis At least one cardiologist and one cardiac surgeon agree that it is difficult for the patient to receive a surgical procedure due to medical factors such that the subject has various comorbidities and he/she is more likely to die or suffer from severe diseases than to have significant improvements by a surgical procedure. 2. Subject has senile degenerative aortic valve stenosis with mean gradient > 40 mmHg, or maximum jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization 3. Subject is symptomatic from his/her aortic valve stenosis (AS), as demonstrated by New York Heart Association (NYHA) Functional Class II or greater. 4. The subject has been informed of the nature of this trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site. 5. The subject or the subject's legal representative agrees to visit the site where he/she receives index procedure for all required post-procedure follow-ups Evidence of an acute myocardial infarction ≤ 30 days (The procedure day is counted as day 0.) before the implant procedure 2. Any percutaneous coronary or peripheral interventional procedures, including placements of bare metal stents are performed within 30 days prior to the implant procedure, or any drug eluting stents are placed within 6 months (One month is counted as 30 days.) prior to the implant procedure 3. Untreated clinically significant coronary artery disease (CAD) requiring revascularization 4. Blood dyscrasias as defined: leukopenia (WBC < 1,000/mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy 5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support 6. Need for emergency surgery for any reason 7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% as measured by resting echocardiogram 8. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to the implant procedure (except mild TIA related to aortic stenosis) 9. End stage renal disease requiring chronic dialysis or serum creatinine > 3.0 mg/dL 10. Active Gastrointestinal (GI) bleeding within 3 months prior to the implant procedure 11. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated Aspirin Heparin (HIT/HITTS) Nitinol (titanium or nickel) P2Y12 inhibitors (such as Ticlopidine etc.) Contrast media 12. Ongoing sepsis, including active endocarditis 13. Subject refuses a blood transfusion 14. Life expectancy < 12 months due to associated non-cardiac comorbid conditions 15. Other medical, social, or psychological conditions that in the opinion of a principal investigator or sub-investigator precludes the subject from appropriate consent 16. Severe dementia (unable to provide informed consent for the treatment/procedure, unable to live an independent life outside of a chronic care facility, or expected to be fundamentally unable to undergo rehabilitation after the procedure, or unable to come to the site for follow-up visits) 17. Currently participating in other trials of investigational drugs or other investigational devices 18. Native aortic annulus size < 21 mm or > 27 mm per the baseline diagnostic imaging 19. Pre-existing prosthetic heart valve and / or prosthetic ring in any position 20. Mixed aortic valve disease (aortic stenosis and predominant aortic regurgitation (3-4+)) 21. Moderate to severe (3-4+) or severe (4+) mitral regurgitation or severe (4+) tricuspid regurgitation 22. Moderate to severe mitral stenosis 23. Hypertrophic obstructive cardiomyopathy 24. New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation 25. Congenital bicuspid or unicuspid valve verified by echocardiograph 26. Extreme eccentric calcification of the native aortic valve 27. Transesophageal echocardiogram (TEE) is contraindicated. 28. Scheduled surgical or percutaneous procedure to be performed prior to 1-month visit post-implant procedure 29. Hepatic failure (Child C or more) 30. Aortic or peripheral condition NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries 31. Thoracic or abdominal aortic aneurysm 32. Woman who is pregnant, breastfeeding or willing to become pregnant | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Disease Signed Informed Consent 2. Age ≥18years of age 3. Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA rating of NYHA ≥ II 4. Has undergone the diagnosis of at least one interventional cardiologist and two cardiac surgeons: the patients are contraindicated for traditional open heart valve replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible complications, or other influential post-operative factors [such as severe calcification in the ascending aorta and aortic valve, weak physical condition, chest deformities, severe liver diseases, severe lung diseases, etc.] or high risk for surgery (LogEuroSCORE≥20% and or STS≥8) 5. Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons that the patient may benefit from a valve implantation 6. Severe aortic stenosis with electrocardiography results as follows: mean transvalvular pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s, aortic valve area < 0.8 cm2 (or AVA index < 0.5 cm2/m2); and/or severe aortic regurgitation, electrocardiography results show symptomatic moderate regurgitation or severe regurgitation 7. Without severe pulmonary arterial hypertension 8. The patient is willing to cooperate with all follow-up visits. Anatomical 9. Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements; 10. Ascending aortic diameter <50mm at the sinotubular junction Patients with infection or who have any sign of infection 2. Previous history of endocarditis or patients with active endocarditis 3. Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non Q-wave MI with creatine kinase, an increase in troponin T) 4. Any cardiac mass discovered during echocardiography, left ventricular or atrial thrombosis 5. Suffering from uncontrollable atrial fibrillation 6. Hereditary hypertrophic cardiomyopathy 7. Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater) 8. Has previously undergone aortic valve implantation (mechanical valve or biological valve frame) 9. Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications, nitinol or porcine products 10. Is known to be contraindicated for or is allergic to all anti-coagulants or is unable to use anti-coagulants during the study 11. Is known to have one of the following conditions (according to evaluations beginning from screening through the day of the procedure) Other diseases that may reduce the life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.) Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.) Plans to undergo surgery that may result in non-compliance with the study protocol or that may cause confusion in data interpretation. 12. Has experienced a cerebrovascular accident (CVA) within the last 6 months 13. Patients suffering from stenosis of the carotid, internal carotid, or vertebral arteries (70%) 14. White cell count <3×109/L, platelet count<50×109/L 15. Hemoglobin <90 g/L 16. Severely lowered left ventricular function, left ventricular ejection fraction < 20 % 17. Aortic aneurysm in the abdomen or chest 18. Hepatic encephalopathy or acute active hepatitis 19. Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L) 20. Prone to bleeding, has a history of clotting disorders or refuses blood transfusions 21. Active ulcer or active gastrointestinal (GI) bleeding 22. Suffering from nervous system diseases that severely influence the patients' ability to move or to perform daily activities 23. Patients with severe dementia 24. Any reason for emergent surgery 25. Taking part in other clinical trials for pharmaceuticals or medical devices 26. Those who are pregnant, plan to become pregnant, or who are taking estrogen or estrogen-like drugs (women suspected of being pregnant must test negative on a urine pregnancy test or for chorionic gonadotropin serum). - | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Atrial Fibrillation Age 18+ on index date Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period Patients must have at least 12 months of continuous prior to the index date Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period Less than 12 months of continuous in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) & PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to patients with "transient" causes of Afib (3 months prior to index date in pre-period) Cardiac surgery Pericarditis Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to patients with "valvular" Afib (pre-period) Mitral stenosis Mitral stenosis with insufficiency Mitral valve stenosis and aortic valve stenosis Mitral valve stenosis and aortic valve insufficiency Diseases of other endocardial structures Other and unspecified rheumatic heart diseases | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 21.0-999.0, Aortic Valve Stenosis Severe AS who underwent TAVR ascending aorta more than 50mm | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 19.0-999.0, Aortic Valve Stenosis The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. 2. The patient has a working diagnosis of aortic stenosis (mild to moderate), and has fair treatment compliance Age under 19 years old 2. Hypersensitivity to PCSK9 inhibitor 3. LDL cholesterol < 70mg/dL at baseline 4. Poor treatement compliance (The patient will need to visit the out-patient clinic every 2-weeks for medication) 5. Positive pregnancy test or is known to be pregnant 6. Any other reason the investigator deems the subject to be unsuitable for the study (e.g., Active malignant tumor, Any life-threatening condition with life expectancy less than 6months, etc.) 7. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Subject has provided written informed consent prior to uploading CT scan to core lab. 2. Subject is ≥ 18 years of age or legal age in host country. 3. Subject's aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 180 days prior to the index procedure. 4. Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by: 1. mean gradient >40 mmHg 2. Peak velocity ≥ 4.0 m/s 3. Doppler Velocity Index <0.25 4. Aortic valve area (AVA) of ≤ 1.0 cm2 or indexed EOA ≤ 0.6 cm2/m2). 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of Class II, or greater or other symptoms of aortic stenosis (e.g. syncope). 6. Subject is deemed high operable risk and preferred TAVI delivery route is alternate access (subclavian/axillary or direct aortic) per the medical opinion of the center's heart team and confirmed by SSC High risk is defined as an STS mortality > 8% or documented heart team agreement ≥ high risk for SAVR due to frailty or co-morbidities Subject is unwilling or unable to comply with all study-required follow-up evaluations. 2. Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to 180 days) prior to the index procedure. 3. Subject has carotid artery disease requiring intervention. 4. Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient index procedure. 5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 6. Subject has severe mitral valvular regurgitation. 7. Subject has severe mitral stenosis. 8. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position. 9. Subject refuses any blood product transfusion. 10. Subject has resting left ventricular ejection fraction (LVEF) less than 20%. 11. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization. 12. Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure. 13. Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement. 14. Subject has a history of, or is currently diagnosed with, endocarditis. 15. There is imaging evidence of intracardiac mass, thrombus, or vegetation. 16. Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance). 17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure. 18. Subject with severe pulmonary disease as determined by STS score. 19. Subject is on chronic oral steroid therapy. 20. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 21. Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis. 22. Subject has morbid obesity defined as a BMI greater than or equal to 40. 23. Subject has ongoing infection or sepsis. 24. Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,). 25. Anatomy falling outside the recommended values in the IFU, unless specifically approved by the Subject Selection Committee. 26. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure. 27. Subject is currently participating in another investigational drug or device study, unless approved by the Sponsor. 28. Subject has/had emergency surgery for any reason within 30 days of the index procedure. 29. Subject has a life expectancy less than 1 year. 30. Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation. 31. Subject is diagnosed with a state of dementia which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits. 32. Subject has a documented allergy to contrast media that cannot adequately be treated, nitinol alloys, porcine tissue, or bovine tissue. 33. Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater 34. Subjects with severe pulmonary hypertension and severe RV dysfunction 35. Subjects with hypertrophic cardiomyopathy Transaortic Subject Cohort Specific Subjects are not eligible for participation in the TAo access arm if they meet any of the following Subject has a chest condition (anatomical or otherwise) that prevents TAo access. 2. Subject has pre-existing patent RIMA graft that would preclude access. 3. Subject has a porcelain aorta, defined as an extensive circumferential calcification of the ascending aorta that would complicate TAo access. Subclavian/Axillary Subject Cohort Specific Subjects are not eligible for participation in the subclavian/axillary access arm if they meet any of the following Subject's access vessel (subclavian/axillary) diameter will not allow for introduction of the 18/19 Fr delivery system. 2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity. 3. Subject has a history of LIMA/RIMA graft that would preclude access | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-80.0, Heart Failure，Congestive Advanced Heart Failure- Individuals with severely reduced left ventricular systolic function that are scheduled to undergo LVAD insertion uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA signal) Individuals with clinical right ventricular failure, defined as moderate-severely reduced RV systolic function on echocardiography, or clinical evidence of RV failure (elevated jugular venous pressures, significant peripheral edema) Individuals with moderate-severe preexisting aortic insufficiency, as these patients will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close the aortic valve and prevent worsening aortic insufficiency; and Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease) Mild Heart Failure - Individuals with medically managed left ventricular systolic function that are NOT scheduled to undergo LVAD insertion HF patients with ejection fraction <35-40% Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC") Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease) History of uncontrolled arrhythmias (e.g. ventricular tachycardia or nonsustained ventricular tachycardia). Healthy Controls - Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications) | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 14.0-999.0, Renal Artery Obstruction Hypertension, Renovascular Age ≥ 14 at the time of informed consent 2. Diameter reduction of renal artery or main branch of renal artery≥ 60%,and ≥2 of four following conditions met:1)systolic hyperemic pressure gradient >20 mm Hg,2)captopril renoscitigraphy positive in the lesion side ,3)renin-angiotensin-aldosterone system significantly activated and 4)severe reduction (>25%) of glomendar filtration rate in the lesion side 3. office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg while receiving 3 antihypertensive drugs,or office systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg without antihypertensive drugs 4. Serum creatinine level<264umol/L 5. Length of ipsilateral kidney ≥7.0 cm and glomendar filtration rate ≥10 ml／min 6. Urine protein <2+ Unable to provide informed consent 2. Unstable condition and unable to tolerate interventional therapy 3. intolerance to antiplatelet drugs or contrast medium 4. vascular anatomy not suitable for endovascular therapy 5. Pregnant, nursing, or planning to be pregnant | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 70.0-999.0, Stenoses, Aortic Valve Age ≥ 70 years Subject has documented calcific, severe native aortic stenosis with an initial AVA of <1.0 cm2 (or AVA index of <0.6 cm2/m2), and a mean pressure gradient ≥40 mm Hg or jet velocity ≥4.0 m/s or doppler velocity index ≤0.25, as measured by echocardiography and/or invasive hemodynamics Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) Subject has symptomatic aortic valve stenosis with NYHA Functional Class ≥ II There is agreement by the heart team (which must a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high operative risk for surgical valve replacement (see note below for definition of high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following Society of Thoracic Surgeons (STS) score ≥ 8% -OR- If STS < 8%, subject has at least one of the following conditions Hostile chest Porcelain aorta Severe pulmonary hypertension (> 60 mmHg) Subject has a congenital unicuspid aortic valve or Sievers Type 2 bicuspid aortic valve Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation) Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment Subject has end-stage renal disease or has serum creatinine > 3mg/dl or has creatinine clearance rate <45ml/min Subject has a pre-existing prosthetic aortic or mitral valve Subject has severe (4+) aortic, tricuspid, or mitral regurgitation Subject has a need for emergency surgery for any reason Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention Subject has platelet count < 50,000 cells/mm3 (50×109/L) or > 700,000 cells/mm3 (700×109/L), or white blood cell count < 1,000 cells/mm3 (1×109/L) | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis severe symptomatic aortic stenosis requiring balloon aortic valvuloplasty cardiogenic shock bilateral absence of radial pulse | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Atrial Fibrillation Aortic Stenosis Severe aortic valve stenosis with an indication for aortic valve replacement (e.g., symptomatic patient, decreased left ventricular (LV) function) Suitable anatomy for transfemoral TAVI with the Portico Transcatheter Aortic Valve System (ileofemoral arterial diameter, annulus-coronary distance, annulus diameter) No mobile thrombus in the LA or LAA precluding LAAO Atrial fibrillation with a CHA2DS2-Vasc-Score >=1. No limitation regarding the nature of atrial fibrillation (paroxysmal, permanent, persistent) Pregnancy Known intolerance to aspirin, heparin, contrast media or clinically manifest nickel allergy Inability to provide informed consent Mechanical heart valve or other indication for oral anticoagulation (i.e. recent pulmonary embolism) Contraindication for oral anticoagulation Currently participating in another trial | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Hypertrophy, Left Ventricular Severe aortic stenosis (aortic valve jet velocity ≥4.0 m/s, or aortic valve area indexed to body surface area <0.6cm2/m2 with aortic jet velocity ≥3.5m/s) 2. Age over 18 years 3. No symptoms attributable to aortic stenosis that require aortic valve replacement Deemed lower risk for mid-wall fibrosis on screening 2. Planned cardiac surgery 3. Previous valve replacement 4. Severe hypertension (systolic >180 or diastolic >110 mmHg) 5. Acute pulmonary oedema or cardiogenic shock 6. Left ventricular ejection fraction <50% on cardiac MRI 7. Significant abnormalities on cardiac MRI that would prevent enrolment 8. Coexistent severe aortic regurgitation or mitral regurgitation 9. Coexistent mitral stenosis greater than mild in severity 10. Coexistent hypertrophic cardiomyopathy or cardiac amyloidosis 11. Any contraindication to MRI scanning (such as permanent pacemaker) 12. Advanced renal impairment (glomerular filtration rate <30 mL/min/1.73 m2) 13. Pregnancy or breast feeding 14. Patient judged to be unfit to be considered for aortic valve replacement or transcatheter aortic valve implantation 15. Patient declines to consider undergoing valve replacement surgery or transcatheter aortic valve implantation 16. Inability to give informed consent 17. Previous randomisation into this study | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortic Valve Stenosis Subject must be ambulatory (with or without an assist device) Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team Subject requires 6.0 seconds or longer to complete a 15ft walk test Subject must be able to move between sitting and standing without assistance from another person Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access Subject is 18 years of age or greater Subject is willing to give consent and participate in the study Subject is incapable of following instructions Subject is unable to meet the minimum required physical therapy visits Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR Subject has significant severe un-revascularized epicardial coronary disease | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Endothelial Dysfunction Aortic Valve Disease Patient ≥ 18 years Patient operated on aortic valvular replacement by bioprosthesis in surgery + CEC or TAVI Signed consent Affiliation to Social Security Any other cardiac surgery Mechanical aortic valve replacement Permanent Ac / Fa Pregnant woman Curative anticoagulation (AVK, NANCO, heparin) Patient under tutelage or curatelle Refusal of the patient Participation in another study Preoperative sepsis Minor or adult, under guardianship or curatorship | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 19.0-85.0, Cardiopulmonary Bypass Cardiac Surgery patients who underwent aortic repair or replacement under moderate hypothermic CPB Preoperative: < 19 years old, > 85 years old, emergency operation, reoperation, left ventricular ejection fraction < 50%, arrhythmia, ischaemic myocardial disease, uncontrollable hypertension or hypotension, pericardial disease, pre-existing hepatic dysfunction, pre-existing renal dysfunction or underlying lung disease Intraoperative: intraoperative application of an intra-aortic balloon pump, administration of steroids or tranexamic acid, and transfusion of fresh frozen plasma or platelet concentrates during CPB Postoperative: reoperation for surgical correction of intractable postoperative bleeding within 2 hours after the end of surgery and transfusion of any banked blood products | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 20.0-70.0, Essential Hypertension Dyslipidemia Voluntarily provided a written consent to participate in this clinical study 2. Male or female adults aged 19-70 years 3. Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1) 4. Uncontrolled blood pressure (140 mmHg ≤ mean Sitting systolic blood pressure(SiSBP) < 180 mmHg) at the baseline visit (V3) after the fimasartan 60 mg monotherapy 5. Subjects who meet the following of fasting serum lipid levels confirmed at the baseline visit (V3) after undergoing the therapeutic lifestyle change (TLC) 6. Treatment compliance of fimasartan 60 mg ≥70% at the baseline visit (V3) 7. Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Severe hypertension with mean Sitting systolic blood pressure(SiSBP) ≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the baseline visit (V2, or orthostatic hypotension accompanied by symptoms 2. Differences between arms greater than 20 mmHg for Sitting systolic blood pressure(SiSBP) and 10 mmHg for Sitting diastolic blood pressure(SiDBP) are present on 3 consecutive readings at the screening visit (V1) 3. Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease) 4. Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit of normal at the pre-baseline visit (V2)) 5. Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular disease, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc. within 6 months prior to the screening visit (V1) 6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator 7. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis 8. Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1) 9. Pregnant or lactating women 10. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods (Contraceptive methods: Refer to Section 10.1 in this document.) | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Disease Severe, calcific bicuspid aortic stenosis. 2. Heart team agrees the patient has a risk of operative mortality and has an STS <8 and >3. 3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath. 2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization. 3. Severe aortic regurgitation (>3+). 4. Severe mitral regurgitation (>3+) | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 19.0-89.0, Heart Failure Age >18 and <90. 2. Established HF with reduced ejection fraction (EF ≤35 %), assessment done within 12 months of index visit. 3. Admitted under observation unit for management of AHF. 4. Heart rate ≥70 beats per minute, with sinus rhythm. 5. Receiving guideline based medical therapy in the judgement of the treating physician. 6. Patient currently on a Beta Blocker regimen. Achieved clinically determined stabilization during treatment under observation unit such that the treating physician is planning to discharge home without hospital admission Known intolerance to study drug. 2. End stage renal disease. 3. Plan to titrate BB at the time of discharge from the observation unit. 4. Any condition that in the opinion of the investigators will interfere with the ability to complete the study (e.g. history of extreme non-adherence, extreme psychosocial instability). 5. Inability to provide written informed consent. 6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (women of childbearing age will be included only if they agree to use adequate contraceptive methods or engage in sexual abstinence). 7. Systolic Blood pressure less than 100 mmHg. 8. Sick sinus syndrome, sinoatrial block or 3rd degree AV block, unless a functioning demand pacemaker is present. 9. Severe hepatic impairment. 10. Pacemaker dependence (i.e. heart rate maintained exclusively by the pacemaker). 11. Concomitant use of strong CYP3A4 inhibitors. Examples of strong CYP3A4 inhibitors azole antifungals (e.g., itraconazole), macrolide antibiotics (e.g., clarithromycin, telithromycin), HIV protease inhibitors (e.g., nelfinavir), and nefazodone. 12. Concomitant use of diltiazem or verapamil that are not planned for discontinuation. 13. Severe, left sided valvular abnormalities (severe aortic stenosis, severe mitral stenosis, severe aortic insufficiency or severe mitral regurgitation. 14. Documented, prior to or at the time of randomization, restrictive amyloid cardiomyopathy, or acute myocarditis, or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Rupture Age ≥ 18 years Supra-coronary aortic diameter measured by CT-scan or transthoracic/trans-esophageal echocardiography between 40 and 45 mm in case of presence of aortic valve disease, bicuspid aortic valve or connective tissue disease and between 40 and 50 mm in case of absence of aortic valve disease, bicuspid aortic valve disease or connective tissue Informed consent for participation in the study Contraindication to MRI Patient's refusal to participate in the study and / or inability to express agreement or signing the informed consent | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Right Ventricular Dysfunction cardiac surgery patients elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement age < 18 | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-65.0, Hypertension,Essential Obstructive Sleep Apnea Left Ventricular Hypertrophy confirmation of resistant hypertension(RAH). RAH was recognized when in spite of the use of at least 3 antihypertensive agents (including a diuretic) in maximum doses, it was impossible to achieve the target values of BP (< 140/90 mmHg) diagnosing of moderate or severe sleep apnea (OSA) on the basis of apnoea-hypopnea index (AHI) in polysomnography. AHI was defined by the total number of apnoea's and hypopneas per hour of sleep. The severity of OSA was determined as: mild (AHI 5-15), moderate (AHI 15 and severe (AHI ≥ 30) signing informed and written consent to participation in the study secondary hypertension (other than primary hyperaldosteronism) myocardial infarction stroke within 6 months before the study congestive heart failure with New York Heart Association (NYHA) grade III-IV chronic kidney disease (GFR < 30 ml/min) active addiction to alcohol or psychoactive substances active cancer disease | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-90.0, Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Coronary artery bypass graft, and mitral/aortic valve replacement patients recovering from sternotomy procedure eligible for cardiac rehabilitation Able to provide written informed consent Male or female 18 years of age or greater Patients with any of the following Serious cardiac arrhythmias Current neurological disorders or previous Cerebral Vascular Accident with residual neurological deficit significant enough to limit exercise Enrolled on another clinical trial that involved exercise Unable to enroll for duration of study Patients who are unable to provide written consent Patients under the age of 18 or over the age of 90 | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Optical Coherence Tomography (OCT) Percutaneous Coronary Intervention (PCI) Single-Photon Emission Computed Tomography (SPECT) Coronary Angiography (CAG) Borderline Coronary Artery Lesions The for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Heart Failure With Normal Ejection Fraction Main/reproducibility group: 1. Ability to provide informed consent 2. Typical HF symptoms (NYHA stage II-III) within the last 6 months 3. EF > 45 % with absence of structural heart disease on echocardiography (except left ventricular hypertrophy or left atrial enlargement) 4. Echocardiographic evidence of increased left ventricular filling pressures 1. E/E'sep >15 OR E/E'lat >12 OR Av E/E' >13 OR 2. E/E' >9 AND left atrial (LA) volume >34 ml/m2 OR systolic pulmonary artery pressure (PAsys): >35 mmHg; 5. Indication for invasive hemodynamic work-up 6. Unclear aetiology of heart failure 7. Adults: age >18 years Patients unable or unwilling to provide informed consent 2. High likelihood of non-diagnostic PV loops of MR imaging (e.g. atrial fibrillation or high rate of premature ventricular contraction (PVC) (> 10 ventricular Extrasystole (VES)/minute), > 150 kg body weight, inability to lie flat or still) 3. Contraindication for invasive work-up (allergy to contrast agent, severe renal insufficiency with estimated glomerular filtration rate (eGRF) <30 ml/min) 4. Contraindications for a contrast enhanced CMR study (allergy to contrast agent, incompatible devices or implants (e.g. non-MR conditional pacemaker), severe claustrophobia) 5. Previous medical history of EF <45% 6. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease) Age-gender matched controls: 1. Ability to provide informed consent 2. No current or history of symptoms, signs or therapy for heart disease 3. EF > 45 % with absence of structural heart disease on echocardiography (except left ventricular hypertrophy or left atrial enlargement) 4. Adults: age >18 years Patients unable or unwilling to provide informed consent 2. High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still) 3. Contraindications for a contrast enhanced CMR study (allergy to contrast agent, incompatible devices or implants (e.g. non-MR conditional pacemaker), severe claustrophobia, severe renal insufficiency with eGRF <30 ml/min)) 4. Previous medical history of EF <45% 5. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease) Healthy volunteers: 1. Ability to provide informed consent 2. No current or history of symptoms, signs or therapy for heart disease 3. EF ≥ 50 % with absence of structural heart disease on echocardiography Contraindications for an MR study 2. High likelihood of non-diagnostic MR imaging (e.g. atrial fibrillation or high rate of PVC (> 10 VES/minute), > 150 kg body weight, inability to lie flat or still) 3. Subjects unable or unwilling to provide informed consent 4. EF <50% in patient history 5. Imaging findings confirming a specific diagnosis of myocardial impairment (e.g. amyloid, ischaemic heart disease, valvular disease) | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Obesity Recent VA primary care measured BMI between 30.0-44.9 kg/m2 (at facility in pacific or mountain time zone) Access to DVD player or internet Able to participate fully in all study protocol/procedures including informed consent Inability to speak, read, or understand English Recent weight loss interventions including use of prescription weight-loss medications, participation in group or individual weight loss programs provided by trained personnel, bariatric surgery (or plans for during the study period) Expected weight loss because of alternate explanations such as from illness High variability in weight due to fluctuations in volume status (ascites liver disease, chronic heart failure) Safety and/or adherence concerns due to severe physical or mental health issues, or life expectancy <24 months Pregnant, lactating, or planning to become pregnant during the study period Participation in other intervention studies | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Coronary Artery Disease Coronary Arteriosclerosis Atrial Fibrillation Left Atrial Abnormality Severe Aortic Stenosis symptomatic severe aortic stenosis patients (defined as aortic valve area of < 1 cm2 or 0.6 cm2/m2 by transthoracic echocardiography) referred to aortic valve replacement diagnosis of acute coronary syndrome in the last 3 months prior history of persistent or permanent atrial or flutter fibrillation coexisting moderate to severe aortic valve regurgitation or moderate to severe mitral valve disease, bicuspid aortic valve left ventricular dilatation [end-diastolic volume index >75 mL/m²] left ventricular ejection fraction <55% chronic renal failure stage 3 to 5 defined as glomerular filtration rate GFR estimated by Cockcroft-Gault formula adjusted for body surface area < 30 mL/min/1.73m² moderate to severe chronic obstructive pulmonary disease defined as forced expiratory volume in one second <50% according to the 2011 Global Initiative for Chronic Obstructive Pulmonary Disease guidelines active malignancy (i.e. With no evidence of recurrence and no longer receiving active treatment) | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 20.0-99.0, Troponin Scheduled for transcatheter aortic valve replacement due to aortic stenosis Transapical approach Pre-procedural PaO2 < 65 mmHg or oxygen support therapy Pre-procedural severe kidney injury (end-stage renal disease) Pre-procedural chronic pulmonary disease, symptomatic asthma Pre-procedural Tb-destroyed lung Lung cancer History of acute coronary syndrome within 6 months History of stroke or transient ischemic attack within 6 months Refuse to participate Pregnant | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Severe Aortic Stenosis Transcatheter Aortic Valve Implantation Severe aortic stenosis (Peak transvalvular gradient of ≥ 40mmHg on TTE or stress Echo, Aortic valve area of < 1.0cm2) Symptoms suggestive of aortic stenosis (dyspnea, syncope, angina) Eligible for TAVI (Upon evaluation by a multidisciplinary team composed of at least one interventional cardiologist and one cardiothoracic surgeon) Severe renal dysfunction Glomerular filtration rate < 30 ml/min Severe left ventricular dysfunction LVEF ≤ 30% Recent coronary angiography ≤ 6months from randomization Recent PCI ≤ 6months from randomization Recent or active acute coronary syndrome (New or worsening angina with or without positive biomarkers or ECG changes) | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Clinical Trial Depression Frail Elderly Syndrome Inflammation Symptomatic aortic valve stenosis Planned elective transcatheter aortic valve replacement Willingness and ability to provide signed informed consent (IC) form prior to participation in any study-related procedures Disease reducing life expectancy to < 1 year Severe immune-system modulating or -affecting disease | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 55.0-999.0, Aortic Stenosis Arteriosclerosis Familial Hypercholesterolemia Conventional Transthoracic Echocardiogram Cases Age ≥ 65 years at the time of cardiac ultrasound Genetically diagnosed HFH or in a first-degree relative History of hypercholesterolemia with LDLc levels> 220 mg / dL without lipid-lowering treatment Controls Genetically Similar Siblings of the normoccholesterolemic case, defined by LDLc <190 mg / dl without lipid-lowering treatment In the absence of available siblings, first cousins may be included In the presence of several siblings available, the same sex will be included Environmentally similar Stable partner of the case with cohabitation> 25 years * Each case will have at least one control Personal history of cardiac rheumatic disease | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Deep Vein Thrombosis Abdominal Aortic Aneurism Pneumothorax Gallbladder Diseases Hydronephrosis Pregnancy, Ectopic Ascites Pleural Effusion Pericardial Effusion Emergency department patient A suspected medical condition, that can be confirmed or excluded by basic POCUS exam, including: free fluid in pleura, pericardium or intraperitoneal space, abdominal aorta aneurysm, gallbladder stones, urine retention, deep venous thrombosis in lower limb, pneumothorax, early pregnancy with non-specified location (confirming intrauterine pregnancy), hydronephrosis Emergency medicine specialist or resident decides to perform a POCUS exam age under 18 not able to give informed consent in Finnish | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Stenosis Myocardial Fibrosis Left Ventricular Hypertrophy (aortic stenosis group) Age over 18 Severe aortic stenosis with planned aortic valve replacement (control group) Age over 18 Planned non-aortic valve cardiac or elective ascending aorta surgery (aortic stenosis group) Coexistent severe aortic or mitral regurgitation Coexistent mitral stenosis greater than mild in severity Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis) Acute pulmonary oedema or cardiogenic shock Coexistent hypertrophic cardiomyopathy Unable to give informed consent (control group) Significant aortic valve disease (mild aortic stenosis / regurgitation or greater) Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis) | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-85.0, Carotid Artery Plaque Atherosclerosis Ischemic Stroke bearing an asymptomatic carotid stenosis of 30-70% in diameter, as established by Doppler-measured peak systolic flow velocity, according to the Society of Radiologists in Ultrasound Consensus Conference (Grant et al. Radiology 2003) pregnancy or possibility of pregnancy history of allergic diathesis history of stroke or transitory ischemic attack previous carotid artery stenting or carotid endarterectomy history of autoimmune vasculitis History of drug abuse, alcohol abuse or any psychiatric or social condition which may contraindicate the participation to a clinical study life expectancy of less than 18 months due to underlying medical conditions presence of cognitive impairment preventing the patient from providing informed consent Atrial fibrillation or previous cardiac surgery or positioning of intracardiac devices (excluded coronary stents) as potential confounding causes of cerebral ischemic damage Known patent foramen ovale (PFO) necessitating anti-platelet treatment | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Hip Disease Males or females over the age of 18 have undergone a THA surgery during the period of interest January 2013 to July 2016) excluded from the study based on the following 1. Concurrent, painful, physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical treatment; 2. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder; and 3. Significant renal or hepatic insufficiency | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 70.0-999.0, Aortic Stenosis Transthyretin Amyloidosis (AS group) Severe aortic stenosis Referred for aortic valve intervention (surgical AVR / TAVI) High clinical suspicion of amyloid (e.g. low-flow low-gradient AS, inappropriate LVH) Age >70 years Willing and able to comply with study protocol (AS group) Inability to give informed consent Contraindication to MRI scanning (e.g. permanent pacemaker) Significant renal impairment (eGFR <30 ml/min/1.73 m2) Coexistent moderate or severe aortic regurgitation or mitral stenosis Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis) Acute pulmonary oedema or cardiogenic shock (Healthy volunteers) No symptoms suggesting current cardiovascular disease Age >70 Willing and able to comply with study protocol | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-90.0, Coronary Artery Disease Aortic Valve Stenosis Age > 18 years 2. Written informed consent 3. Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team 4. Diagnosis of at least one coronary stenosis >50% at angiography 5. No specific pharmacologic treatment is required to enter the study Age < 18 years 2. Pregnancy 3. Lack of informed consent 4. Impaired left ventricular function 5. Signs or symptoms of acute (unstable) myocardial ischemia 6. Contraindication to adenosine administration (e.g., asthma, chronic obstructive pulmonary disease, heart rate <50 beats/min, and systolic blood pressure <90 mmHg) 7. Reduced survival expectancy due to severe co-morbidities (<1 year) 8. Impossibility to obtain follow-up information 9. The lack of any of | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Carotid Arteries Patients presenting a. to the neurologist for evaluation of stroke or TIA (Symptomatic) with: i. Symptomatic patients with plaque ≥70% in at least one carotid artery that would be implicated as the source of embolus responsible for the stroke/TIA. b. or to the vascular surgeon for CEA (Asymptomatic) with: i. asymptomatic patients with a luminal stenosis of ≥70% in at least one carotid artery (stable plaque) referred for CEA ii. age-matched by deciles to symptomatic patients stroke due to atrial fibrillation, 2. preexisting carotid stents in the artery of interest, 3. renal dysfunction defined as glomerular filtration rate (GFR) <40ml/min, 4. allergy to gadolinium based contrast agents, 5. Volunteers who have had four or more prior previous gadolinium contrast scans 6. metal implants incompatible with MRI or other condition that prohibits MRI, 7. pregnancy, 8. inability to provide informed consent and 9. age ≤18 years | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Patients who underwent transcatheter (TAVI) or surgical aortic valve replacement (SAVR) for severe aortic valve stenosis Patients aged >18 years Primary aortic valve procedure with a bioprosthesis for AS with or without associated regurgitation TAVI and SAVR with or without associated coronary revascularization TAVI and SAVR for AS after any prior major cardiac surgery with exception of any maze procedure and/or closure of the left atrial appendage Patients who underwent any prior SAVR or TAVI Patients undergoing concomitant procedures on the mitral valve, tricuspid valve or the ascending aorta Patients operated on for aortic valve endocarditis Patients operated for isolated aortic valve regurgitation | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 21.0-80.0, Aphasia Stroke Stroke, Ischemic Aphasia, Broca Aphasia, Global Aphasia, Mixed Aphasia, Jargon Aphasia, Expressive Aphasia, Conduction Aphasia, Fluent Aphasia, Anomic Experienced a left hemisphere ischemic or hemorrhagic stroke At least 12 months post-stroke Primarily English speaker for the past 20 years Ability to provide informed written or verbal consent MRI-compatible (e.g., no metal implants, not claustrophobic) History of a right hemisphere stroke (Bilateral stroke) Clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems Severely limited speech production and/or auditory comprehension that interferes with adequate participation in the therapy provided | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortopathies Thoracic Aortic Aneurysm Aortic Valve Disease Thoracic Aortic Disease Thoracic Aortic Dissection Thoracic Aortic Rupture Ascending Aortic Disease Descending Aortic Disease Ascending Aortic Aneurysm Descending Aortic Aneurysm Marfan Syndrome Loeys-Dietz Syndrome Ehlers-Danlos Syndrome Shprintzen-Goldberg Syndrome Turner Syndrome PHACE Syndrome Autosomal Recessive Cutis Laxa Congenital Contractural Arachnodactyly Arterial Tortuosity Syndrome Open to external enrollment Subjects with a genetic diagnosis of Marfan Syndrome (MDS), Loeys-Dietz Syndrome (LDS), or Vascular Ehlers-Danlos Syndrome (EDS); (Positive genetic testing or a previous cardiac study required to be eligible) Family members of eligible subjects (Only family members of subjects with syndromic diagnoses are eligible for external enrollment at this time) Closed to external enrollment Subjects with aortic disease including TAA* or dissection, aortic tortuosity, or aortic hypoplasia/stenosis (based on any cardiac imaging modality including echocardiography, CT, MRI, or angiography) Subjects with aortic valve disease (bicuspid, unicuspid, or tricuspid disease) Control subjects having tissue removed during a surgical procedure (e.g. coronary artery bypass graft surgery (CABG), cardiac transplant, etc.) • Inability or unwillingness to provide consent (assent when indicated) | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 20.0-110.0, Coronary Artery Stenoses Aortic Stenosis All patients who have coronary stenoses between 40-70% severity and who have severe aortic stenosis undergoing TAVR work-up Patients with documented intraprocedural hemodynamic instability, shock, or major adverse event (myocardial infarction, aortic rupture/dissection, stroke, left ventricular perforation, cardiac arrest) Contraindication to adenosine, presence of cardiogenic shock, presence of acute coronary syndrome | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortic Stenosis Symptomatic patients with severe aortic stenosis Institution heart team determines that aortic valve replacement neoTM device using its transapical delivery system is appropriate Patients unable or unwilling to give inform consent | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Mitral Regurgitation Heart Murmurs Valvular Heart Disease Able to provide consent Undergoing a complete echocardiogram Refusal to participate | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 19.0-999.0, Aortic Stenosis Symptomatic Aortic Stenosis Aortic Regurgitation Subjects who are considered to be operable and high risk for surgical valve replacement: STS Score ≥ 8 and ≤ 15 or Logistic EuroSCORE ≥ 15 and ≤ 40. If STS score is below 8 and Logistic EuroSCORE is below 15, patients should have other clinical or anatomical risk factors that would be considered high risk for surgery and documented by the heart team. 2. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by one or more of the following within 60 days prior to the index procedure: AVA < 0.8 cm2, Indexed AVA <0.5 cm2/m2, mean gradient > 40mmHg, or peak aortic jet velocity > 4.0m/sec. 3. NYHA Functional Class II or greater. 4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the EC of the respective clinical site. 5. The study patient agrees to comply with all required postprocedure follow-up visits Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment. 2. Aortic valve is a congenital unicuspid or is non-calcified. 3. Aortic valve is bicuspid and the patient is less than 60 years old, or the aortic valve is bicuspid with no raphe (Sievers classification type 0). 4. Anomalous coronary artery that would interfere with proper placement of the valve. 5. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+) | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 30.0-90.0, Coronary Artery Disease Aortic Valve Stenosis Mitral Valve Insufficiency An eligible patient with coronary artery disease, aortic valve stenosis or mitral valve insufficiency scheduled for elective coronary artery bypass grafting, aortic valve replacement or mitral valve repair operation He / she does not have any severe disease or functional limitation limiting PA (other than CVD) He / she is willing to wear a hip and wrist-worn accelerometer He / she is willing and capable to use a smart phone application He / she ends up in prolonged intensive care after cardiac operation He / she has a memory disorder (i.e. Alzheimer's disease) | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortic Valve Stenosis Severe, calcific aortic stenosis meeting the following transthoracic echocardiogram Aortic valve area ≤ 1.0 cm2 OR aortic valve area index ≤ 0.6 cm2/m2 Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg 2. New York Heart Association functional class ≥ II 3. Judged by the Heart Team to be at intermediate risk for open surgical therapy 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent Native aortic annulus size unsuitable for available THV sizes on 3D imaging analysis 2. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position. 4. Severe aortic regurgitation (> 3+) 5. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis 6. Ventricular dysfunction with left ventricular ejection fraction < 30% 7. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 8. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure 9. Subjects with planned concomitant ablation for atrial fibrillation 10. Hypertrophic cardiomyopathy with obstruction 11. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR 12. Complex coronary artery disease: 1. Unprotected left main coronary artery 2. score > 32 3. Heart Team assessment that optimal revascularization cannot be performed 13. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath 14. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system 15. Active bacterial endocarditis within 180 days of the valve implant procedure 16. Stroke or transient ischemic attack within 90 days of the valve implant procedure 17. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure 18. Severe lung disease (Forced Ejection Volume 1 < 50% predicted) or currently on home oxygen 19. Severe pulmonary hypertension 20. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure 21. History of cirrhosis or any active liver disease 22. Renal insufficiency and/or renal replacement therapy at the time of screening 23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states 24. Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure 25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication 26. Significant frailty as determined by the Heart Team 27. Subject refuses blood products 28. Body mass index > 50 kg/m2 29. Estimated life expectancy < 24 months 30. Positive urine or serum pregnancy test in female subjects of childbearing potential 31. Currently participating in an investigational drug or another device study | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Bicuspid Aortic Valve Adults over 18 years of age confirmed BAV by TTE computed tomography or MRI Adults benefiting from a social security scheme having received information on the research having signed the consent form Patient with a syndromic form of BAV Loeys-Dietz syndrome Turner syndrome Williams-Beuren syndrome Shone syndrome | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Bicuspid Aortic Valve Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment. 5. Estimated life-expectancy>1 year Age <18 years 2. Asymptomatic patients 3. Estimated life expectancy<1 year 4. Pure aortic regurgitation. 5. LVEF<20% 6. No baseline MSCT evaluation. 7. Unsuitable aortic root anatomy for Evolut Pro or XL. 8. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Fontan Procedure This study will includeall patients referred for an elective TCPC procedure at the period of the study, who demonstrated a standard risk profile Preoperative evaluation consisted of ECG, transthoracic echocardiogram, and complete cardiac catheterization. Patients with the following parameters will be eligible for enrollment in the study Sinus Rhythm Atriovnetricular valve regurgitation not more than mild Aortic (neoaortic) valve regurgitation not more than mild Normal systolic dominant ventricle function Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge pressure) Pulmonary vascular resistance not more than 2 woods unit End diastolic ventricular filling pressure not more than 8 mm Hg Patient with the following will not be eligible for Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or interventional additional procedures before or during the Fontan operation | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Right Bundle-Branch Block Heart Failure With Reduced Ejection Fraction Bifocal Stimulation Patients with RBBB and HFrEF (defined by left ventricular ejection fraction ≤35%) in sinus rhythm, who remain in NYHA class II-III or ambulatory NYHA class IV despite OMT Refusal or withdrawal of informed consent Renal failure (defined by an estimated glomerular filtration rate ≤ 60 ml/min) Life expectancy < 12 months Active neoplasm Permanent atrial fibrillation days following acute coronary syndrome Atrio-ventricular block (from second degree AV block) Valvular heart disease with surgery indications | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Right Ventricular Dysfunction Rheumatic Heart Disease All ages will be accepted Isolated mitral valve lesion either stenosis or regurge Good LV function (EF <45%) Any degree of tricuspid valve regurge Concomitant Aortic valve lesion needs replacement Poor LV function (Low EF> 45%) Other causes of pulmonary hypertension i.e.: (Chronic obstructive or restrictive pulmonary disease, connective tissue disease and chronic thromboembolism) Emergency and Redo operations | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-85.0, Heart Failure With Normal Ejection Fraction Left Ventricular Hypertrophy Aortic Valve Stenosis Diabetes Group 1: Healthy Volunteers (n = 30) Healthy adults with no known history of medical disease Age 18-85 years No history cardiovascular disease Ability to provide informed consent Group 2: Patients with Diabetes (n = 16) Age 18-85 years Diagnosis of diabetes Echocardiogram within last 12 months showing no evidence of left ventricular hypertrophy or hemodynamic findings consistent with heart failure with preserved ejection fraction Ability to provide informed consent Group 3: Patients with Aortic Stenosis (n = 50) Age 18-85 years Known contraindication to MRI | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortic Valve Stenosis Arrythmia Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure Prior permanent pacemaker | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis elective patients with a diagnosis of severe symptomatic aortic stenosis and admitted for TAVI patients not providing written informed consent | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 20.0-999.0, Aortic Valve Aortic Valve Insufficiency Aortic Regurgitation Regurgitation, Aortic Valve Aortic Incompetence Patients must have co-morbidities such that the principal investigator and co-investigator concur that the predicted risk of operative mortality is ≥15% (STS score ≥10 OR Logistic EuroSCORE ≥20%). A candidate who does not meet [the STS score ≥ 10 OR Logistic EuroSCORE ≥20%] can be included in the study if a peer review by at least two investigators concluded and documented that the patient's predicted risk of operative mortality is ≥15% from old age, severe frailty or STS score ≥8. In this case, all evidence must be documented in the study case report form as well as in the patient medical record. 2. There is a formal agreement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to the relevant guideline. 3. The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation. 4. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. 5. The subject agrees that the subject will keep in touch with study team for all required post-procedures like angiography or transesophageal echography. 6. The subject agrees that the subject will cooperate with study team for all required post-procedure visits. 7. The subject's age is 20 or more Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition). 2. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug-eluting coronary stent implantation). 3. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg%), thrombocytopenia (platelet count <50,000 cells/mm³), history of bleeding diathesis or coagulopathy. 4. Untreated clinically significant coronary artery disease requiring revascularization. 5. Need for emergency surgery for any reason. 6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 7. Active bacterial endocarditis or other active infections. 8. Active peptic ulcer or upper GI bleeding within the prior 3 months. 9. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated. 10. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA). 11. Life expectancy < 12 months due to non-cardiac comorbid conditions. 12. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend or angle of aortic arch ≥200 degree),aortic arch atheroma (especially if thick [> 5mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only). 13. Root disease including annuloaortic ectasia or aneurysm of root or sinus. 14. Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity(with moderate or severe calcification and two or more severe curve (angle ≥90°) (applicable for transfemoral patients only). 15. Pregnant(positive result from pregnancy test conducted during screening visit and within prior 2 weeks of valve replacement) or lactating women | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-18.0, Hypertension, Pulmonary -patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart active systemic infection current active cancer active cancer treatment prior bone marrow transplant prior solid organ transplant | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Chest Pain Coronary Artery Disease Acute Coronary Syndrome Ischemic Heart Disease Patients above 18 years of age with ischaemic sounding chest pain prompting visit to the emergency department (suspected ACS). 2. No-ischaemic ECG changes (i.e. no ST-segment elevation or depression 1mm in 2 or more contiguous leads, and/or T-wave inversions). 3. Episode of chest pain within last 12 hours. 4. Initial troponin in the intermediate range (5-50ng/L) STEMI. 2. Signs and symptoms of acute heart failure and/or haemodynamic instability. 3. Dynamic ischaemic ECG changes. 4. Patient not suitable to undergo CTCA 1. Inability to breath hold for 10 seconds 2. Severe renal impairment (eGFR <30 mL/min) 3. Contraindication to beta-blockers (not relevant for patients with baseline sinus rhythm at rate of <63bpm) 5. Atrial Fibrillation on ECG. 6. Patients with known significant obstructive coronary artery disease (>50% stenosis) on previous invasive or CT coronary angiogram. 7. Patients with previous PCI/CABG revascularisation. 8. Patients with a history of congenital heart disease. 9. Patients with known coronary artery anomalies. 10. Patients who lack capacity to give consent or participate in the study. 11. Previous recruitment to the present study. 12. Known pregnancy or patients who are currently breast feeding. 13. Prisoners. 14. Patients involved in current or a recent (within the last 4 months) CTIMP trial | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Stenosis, Calcific Severe aortic stenosis (aortic valve area <1.0cm2 or aortic valve area index <0.6 cm2/m2 Age ≥18 years Signed informed patient consent form Severe valvular disease other than AS Significant coronary heart disease requiring revascularisation History of myocardial infarction Previous cardiac surgery Severe renal impairment eGFR <30ml/min/1.73m2 Any absolute contraindication to CMR Inherited or acquired cardiomyopathy Other medical conditions that limits life expectancy or precludes SAVR or TAVI Pregnant or nursing women Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortic Valve Stenosis patients undergoing transfemoral transcatheter aortic valve procedures valve-in-valve procedures, other acces routes than transfemoral | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Insufficiency Aortic Stenosis Mitral Insufficiency Mitral Insufficiency and Aortic Stenosis Tricuspid Regurgitation Insufficiency, Pulmonary Insufficiency, Tricuspid Adults with a heart defect verified by echocardiography | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 17.0-75.0, Aortic Valve Replacement 75 years old patients with sever aortic valve stenosis undergoing valve replacement surgery informed consent has been obtained Planned off-pump cardiac surgery Patients required intra-aortic balloon pump under 17 years of age | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Functional Mitral Regurgitation Adults ≥18 years of age 2. Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2) 3. NYHA Class II to IV 4. Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography 5. Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days 6. Subjects with a Class I indication for CRT implant according to current guidelines should have CRT implant prior to entry into the study. Subjects who have existing CRT implants may be included in the study if the implant has been in place for at least 90 days; reprogramming of an implanted CRT that results in increased biventricular pacing (from <92% to ≥92%) must be in place for at least 30 days. 7. Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography 8. Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA)) 9. Subject is willing and available to return for study follow-up 10. Subject or legal representative understands and provides signed informed consent for participation in study 11. Acceptance of subject for trial enrollment after review of all subject baseline data by Study Selection Committee Life expectancy of less than 12 months due to conditions other than cardiac status 2. Anticipated need for LVAD or transplant within 12 months 3. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use 4. American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure 5. Six-minute walk distance < 150 meters 6. Identified need for any cardiovascular surgery 7. STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee 8. Untreated clinically significant coronary artery disease 9. Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads, pericarditis, or other procedure involving pericardial access) 10. Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI myocardial infarction, unstable angina) or clinically significant cardiac events (e.g. hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any hospitalization) within 30 days of enrollment 11. Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis) 12. Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion) 13. Severe symptomatic carotid stenosis 14. Severe or sustained pulmonary hypertension, defined by resting pulmonary artery systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart catheterization 15. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction or moderate to severe TR 16. Hypotension (systolic pressure <90 mmHg) 17. Hemodynamic instability requiring inotropic support or mechanical heart assistance within 30 days 18. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart disease causing heart failure other than dilated cardiomyopathy 19. UNOS status 1 heart transplantation 20. Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis 21. Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of enrollment 22. Active systemic infection or bleeding 23. Autoimmune disorders and/or the use of immune suppression therapy 24. Females who are pregnant (as documented by HCG beta pregnancy test in females of child-bearing age) or lactating 25. Currently enrolled in another investigational drug or device study Intra-Operative Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion) 2. Signs/indications of ischemia 3. Intra-operative coronary angiography demonstrates that there is compression of the coronary arteries or reduction in coronary blood flow due to the VenTouch implant | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Subject has documented severe aortic stenosis defined as initial AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mm Hg OR maximal aortic valve velocity ≥4.0 m/s OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended)c; the subject may be enrolled if echocardiographic are met with this augmentation. (IC1) A subject in the Bicuspid Aortic Valve Nested Registry cohort must have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab with hemodynamic parameters that meet the in IC1 Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) Subject has symptomatic aortic valve stenosis per IC1 definition above with NYHA Functional Class ≥ II Heart team (which must an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is at intermediate risk of operative mortality (≥3% and <8% at 30 days based on the Society of Thoracic Surgeons [STS] risk score and other clinical comorbidities unmeasured by the risk calculator) and TAVR is appropriate. Note: Risk of operative mortality must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must an experienced cardiac surgeon) Heart team agrees that the subject is likely to benefit from valve replacement. IC7. Subject (or legal representative) has been informed of the study requirements and the treatment procedures, and provides written informed consent Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow-up visits Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the Bicuspid Nested Registry cohort) Subjects in the Bicuspid Nested Registry cohort will have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab. Subjects are not eligible for in the Bicuspid Nested Registry cohort if the maximum diameter of the ascending aorta is >45 mm or if the subject has another indication for aortic root replacement. Subjects with a Sievers Type 2 bicuspid valve are not eligible for enrollment in any study cohort Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation) Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment Subject is on renal replacement therapy or has GFR <20 (based on hospital preferred method). See AEC1 below if subject is in the CT Imaging Substudy Subject has a pre-existing prosthetic aortic or mitral valve Subject has severe (4+) aortic, tricuspid, or mitral regurgitation Subject has moderate to severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or Dc) Subject has a need for emergency surgery for any reason Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Morality Retrospectively, all patients examined from January 1, 2000 to November 2014 will be included in the echocardiography laboratory whose objective examination is a narrowing of the aortic valve (maximum transaortic velocity ≥2.5 m / s) Aortic stenosis may be known in the past Refusal of the patient to participate in the study Patients who have previously had aortic valve surgery before being examined in the echocardiography laboratory Patients who can not be contacted or who do not respond will not be included in the database | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Aortic Valve Stenosis Patients with severe symptomatic aortic stenosis undergoing TAVI Patients with concomitant valvular heart disease | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 60.0-999.0, Bicuspid Aortic Valve Severe aortic stenosis, defined as follows: 1. For symptomatic patients: Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest 2. For asymptomatic patients: Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%. 2. Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment. 3. Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT. 4. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve). 2. Age less than 60 years 3. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated: 1. aspirin or heparin (HIT/HITTS) and bivalirudin 2. ticlopidine and clopidogrel 3. Nitinol (titanium or nickel) 4. contrast media 4. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states. 5. Ongoing sepsis, including active endocarditis. 6. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval. 7. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery. 8. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment. 9. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 10. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 11. Gastrointestinal (GI) bleeding that would preclude anticoagulation. 12. Subject refuses a blood transfusion. 13. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). 14. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions. 15. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams. 16. Currently participating in an investigational drug or another device study (excluding registries). 17. Evidence of an acute myocardial infarction ≤30 days before the study procedure due to unstable coronary artery disease (WHO criteria). 18. Need for emergency surgery for any reason. 19. Subject is pregnant or breast feeding. 20. Subject is legally incompetent, or otherwise vulnerable Anatomical Pre-existing prosthetic heart valve in any position. 22. Severe mitral regurgitation amenable to surgical replacement or repair. 23. Severe tricuspid regurgitation amenable to surgical replacement or repair. 24. Moderate or severe mitral stenosis amenable to surgical replacement or repair. 25. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient. 26. Prohibitive left ventricular outflow tract calcification. 27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis 28. Aortic annulus diameter of <18 or >30 mm. 29. Significant ascending aortopathy requiring surgical repair 30. Ascending aorta diameter > 4.5 cm For transfemoral or transaxillary (subclavian) access: 31. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-999.0, Assessment of the RV Function in Patients With Heart Faliure - Adult patients of both gender who have the followiong : (i) symptoms with or without signs of HF (ii) elevated natriuretic peptides (BNP ≥35pg/ mL or NT-proBNP≥125pg/mL) (iii) relevant structural heart disease: left ventricle hypertrophy (left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or left atrial enlargement (>34 mL/m2) or diastolic dysfunction (E/e'≥13 and a mean e' septal and lateral wall <9 cm/s) were included. Then patients were classified according to EF into HFpEF>50%, HFrEF<40% and HFmrEF >40% and <50% Patients with chronic obstructive pulmonary disease history of pulmonary embolism patients with respiratory failure | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 19.0-80.0, Aortic Stenosis Aortic Regurgitation Hypertension LVM Left Ventricular Hypertrophy Male or female aged ≥ 19 years and < 80 years 2. Diagnosis of mild-moderate AS or mild-moderate AR 3. Applicable to 2.0~3.9 m/s of aortic jet velocity for mild-moderate AS or to 0.2~0.6 cm of Vena contracta for mild-moderate AR 4. Diagnosis of hypertension (SBP > 130 mmHg if being treated or SBP > 140 mmHg if being untreated) 5. For females of childbearing potential; negative pregnancy test results during the screening period and prior to administration of the investigational product, and agreement on use of medically allowable contraceptive measures (condom, oral contraceptive pills, injectable or implantable contraceptives, intrauterine devices, birth control patches, etc.) during the study period 6. Voluntary written consent to taking part in the clinical study and willingness to comply with requirements of the study History of a cardiac valve replacement surgery (replacement surgery of mitral valve, aortic valve or tricuspid valve) 2. Accompanied by severe mitral regurgitation 3. Admitted to needing a surgery by the current treatment guidelines 4. Accompanied by symptoms such as angina pectoris, exertional dyspnea, syncope, etc. 5. < 50% of left ventricular ejection fraction 6. History of hypersensitivity reaction to active ingredients of the investigational product (Amlodipine, Losartan and Chlorthalidone), dihydropyridine derivatives, thiazide drugs and other sulfonamide derivatives or their compositions 7. Pregnant or breastfeeding 8. Symptomatic orthostatic hypotension 9. Severe liver failure or renal failure (< 30 mL/min of creatinine clearance) 10. Hereditary angioedema or history of angioedema at treatment with ACE inhibitors or angiotensin II receptor blockers 11. Primary hyperaldosteronism 12. Genetic problems such as galactose intolerance, Lapp Lapp lactase deficiency or glucose-galactose malabsorption 13. Anuria 14. Refractory hypokalemia 15. Hyponatremia or hypercalcemia 16. Symptomatic hyperuricemia (history of gout or uric acid lithiasis) 17. Untreated Addison's disease 18. Appropriately uncontrolled diabetes 19. Congenital or incurable hypertension 20. Diagnosis of severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.) within six months prior to the date of ICF obtainment 21. Wasting disease, autoimmune disease or connective tissue disease 22. Diagnosis of malignant tumor within five years prior to the date of ICF obtainment 23. Administration of another investigational product within four weeks prior to the date of ICF obtainment 24. For a patient who is taking anticoagulants and thrombolytic agents; considered difficult to keep a stable dosage/regimen by the investigator. 25. Considered unsuitable to be a subject by the investigator | 1 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-49.0, Cystic Fibrosis (HV Subjects): 1. Written informed consent given by the subject. 2. At least ≥ 18 years old and < 50 years of age. 3. Healthy with no acute medical condition for ≥ 2 weeks prior to screening and no known chronic medical condition requiring regular medical follow up and care. 4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive. 5. Currently nonsmoking and no history of using nicotine/tobacco-containing products for ≥ 5 years prior to screening. 6. Normal chest X-ray, per opinion of the Investigator. 7. FEV1 ≥ 80% of predicted values. 8. No history or current illicit, pharmaceutical drug or alcohol abuse within ≤ 5 years prior to screening. 9. A female subject must meet one of the following If of childbearing potential agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 90 days after the last dose of the study medication. An acceptable method of contraception includes one of the following Abstinence from heterosexual intercourse Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) Intrauterine device (with or without hormones), OR Agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 90 days after the last dose of the study medication If a female of non-childbearing potential, the subject should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels. 10. A male subject must agree to use a double barrier method (e.g., condom and spermicide) during the study and for at least 90 days after the last dose of the study medication. (CF Subjects): 1. Written informed consent given by the subject. 2. At least18 years old 3. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following Sweat chloride equal to or greater than 60 mmol/liter by quantitative pilocarpine iontophoresis test (QPIT) Two well-characterized, disease-causing mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 4. Confirmation of prior and current colonization/infection with P. aeruginosa defined as: at least 2 positive cultures for PA in the last 12 months and a positive culture at screening. 5. Respiratory symptoms and CF status are stable with no acute exacerbation at the time of randomization. 6. Subject either using 1 alternating monthly suppressive inhaled antimicrobial therapy (at the time of randomization) OR using no suppressive inhaled antimicrobial therapy. 7. BMI between 18 and 30 kg/m2, inclusive. 8. Currently non-smoking and no history of using nicotine/tobacco-containing products or smoking/vaping (inhaled tobacco products or other inhaled substances) for ≥ 1 year prior to screening. 9. 1st 3 sentinels subjects in each dose group must have a FEV1 ≥ 60% of predicted values. The remaining 3 sentinel subjects and expanded dosing cohort in each dose group must have a FEV1 ≥ 45% of predicted values. 10. Serum creatinine and total bilirubin are both < 1.5 x upper limit of normal (ULN) range (isolated bilirubin > 1.5 x ULN range is acceptable if bilirubin is fractionated and direct bilirubin is < 35%). 11. A female subject must meet one of the following If of childbearing potential agrees to use one of the accepted contraceptive regimens from at least 21 days prior to the first administration of the study medication, during the study, and for at least 28 days after the last dose of the study medication. An acceptable method of contraception includes one of the following (HV Subjects): None of the following can be met. 1. Female subjects who are currently pregnant or lactating. 2. Oral temperature above 37.5ºC at the time of screening or prior to randomization. 3. Clinically abnormal renal function, evidenced by serum creatinine > 1.5 mg/dL. 4. Need for using any nephrotoxic agents during the study. 5. Known allergy or hypersensitivity to albuterol. 6. Significantly abnormal liver function: 1. Total bilirubin >1.5 x upper limit of the normal range (ULN), 2. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 x ULN and alkaline phosphatase (ALP) > 2 x ULN 7. Hemoglobin <10 g/dL 8. Abnormal corrected serum calcium concentration prior to enrollment. 9. History or current use of illicit, pharmaceutical drug or alcohol abuse within 5 years prior to screening. 10. Positive urine screen for alcohol, cotinine and/or drugs of abuse at screening and admission. 11. Positive test results for Human Immunodeficiency Virus (HIV)-1/HIV-2 antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCVAb). 12. Inability to comply with any study requirements based on judgement of the Investigator. 13. Any medical, psychological, cognitive, social or legal conditions that would interfere in the ability to give an informed consent and/or participate fully in the study. 14. Participation in another clinical trial involving receipt of an investigative product within 30 days before screening. 15. Any other reason as determined by an Investigator (CF Subjects): None of the following can be met. 1. Female subjects who are currently pregnant or lactating. 2. Oral temperature above 37.5ºC at the time of screening or prior to randomization. 3. Serum creatinine > 1.5 mg/dL or known significant kidney disease. 4. Significantly abnormal liver function: 1. Total bilirubin > 1.5 x ULN range, 2. ALT and/or AST > 3 x ULN range and ALP > 2 x ULN range. 5. History of medically attended hemoptysis, requiring hospitalization (small amount of blood streaking in sputum is acceptable). 6. Pulmonary exacerbations within 3 months prior to randomization. 7. Hemoglobin < 10 g/dL. 8. Abnormal corrected serum calcium concentration prior to randomization (normal range is typically 8.5-10.2 mg/dL). 9. Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or CF-related conditions within 2 weeks prior to randomization. 10. Known allergy or hypersensitivity to albuterol or any component of the study drug or placebo 11. History or current use of illicit, pharmaceutical drug or alcohol abuse within 5 years prior to screening. 12. Positive urine screen for alcohol, cotinine and/or drugs of abuse at screening (positive results for a subject on Orkambi should have a confirmatory test for cannabinoids performed, e.g., reflex testing, to rule out cross reaction with Orkambi) 13. History of positive test result for human immunodeficiency virus (HIV) HIV-1/HIV-2 antibodies, HBsAg or chronic hepatitis C virus infection. 14. Inability to comply with any study requirements based on judgement of the Investigator. 15. Any medical, psychological, cognitive, social or legal conditions that would interfere in the ability to give an informed consent and/or participate fully in the study. 16. Participation in another clinical trial involving receipt of an investigative product within 30 days before randomization. 17. Suspected or confirmed acute respiratory infection (Examples: bacterial pneumonia, influenza, COVID-19). 18. Any other reason as determined by an Investigator | 0 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 0.0-999.0, Valvular Heart Disease (Aortic and Mitral Valves) Patients with clinically diagnosed valvular heart disease and confirmed by echocardiography Patients with known contraindication to MRI including the presence of paramagnetic Surgical clips, or pacemakers Severely ill patients Claustrophobic or restless subjects Patients with arrhythmia | 2 |
48 M with a h/o HTN hyperlipidemia, bicuspid aortic valve, and tobacco abuse who presented to his cardiologist on [**2148-10-1**] with progressive SOB and LE edema. TTE revealed severe aortic stenosis with worsening LV function. EF was 25%. RV pressure was 41 and had biatrial enlargement. Noted to have 2+ aortic insufficiency with mild MR. He was sent home from cardiology clinic with Lasix and BB (which he did not tolerate), continued to have worsening SOB and LE edema and finally presented here for evaluation. During this admission repeat echo confirmed critical aortic stenosis showing left ventricular hypertrophy with cavity dilation and severe global hypokinesis, severe aortic valve stenosis with underlying bicuspid aortic valve, dilated ascending aorta, mild pulmonary artery systolic hypertension. The patient underwent a preop workup for valvular replacement with preop chest CT scan and carotid US (showing moderate heterogeneous plaque with bilateral 1-39% ICA stenosis). He also underwent a cardiac cath with right heart cath to evaluate his pulm art pressures which showed no angiographically apparent flow-limiting coronary artery disease. | eligible ages (years): 18.0-75.0, Acute Decompensated Heart Failure Patients are eligible for enrollment if within the previous 24 hours they were treated with acute decompensated heart failure or diagnosed on the basis of the investigator's clinical diagnosis of heart failure, which needs to be supported by at least 2 the following Elevated concentration of B-type natriuretic peptide (BNP) or N-terminal pro-BNP. (Elevated BNP" defined as >300 for sinus rhythm, >500 for patients will atrial fibrillation and elevated pro BNP defined as >1000 for sinus rhythm, >1600 for atrial fibrillation.) Pulmonary edema on physical examination Radiologic pulmonary congestion or edema History of Chronic Heart Failure. Anticipated need for IV loop diuretics for at least 48 hours Willingness to provide informed consent Previously diagnosed end-stage renal disease; Serum Potassium >5.5 mmol/L Cardiogenic Shock within 48 hours, ST-segment elevation myocardial infarction, ongoing ischemia Need for renal replacement therapy through dialysis or ultrafiltration Myocardial infarction within 30 days of screening Patients with systolic blood pressure of less than 90 mm Hg Patients requiring Intravenous Vasodilators or inotropic agents (other than Digoxin) for heart failure BNP less than 250 ng/ml and/or proBNP less than 1000 mg/ml Pregnant women, prisoners, and institutionalized individuals Severe stenotic valvular disease Complex congenital heart disease | 1 |