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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): 65.0-75.0, Ischemia Coronary Artery Origin patients between 65 and 75 years with physical status of ASA II and IV who underwent aortic valve replacement (for isolated or mixed aortic valve lesions) alone or in addition to-coronary artery bypass grafting. in the Cardio-thoracic Surgery Department of Tanta University Hospital during a two year period were enrolled in this study Before in the study, all patients were evaluated with extended echocardiographic imaging, full history including cardiac symptoms (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and low cardiac output symptoms) was taken from all patients. General (including body weight and height) and systematic (including cardiac examination) examinations were done to all patients Patients with an ejection fraction of 0.3, myocardial infarction within the last 4 weeks diabetes severe pulmonary or arterial hypertension a contraindication for HTEA patients without preoperative optimal echocardiographic imaging were excluded Among the were the administration of ticlopidine within 15 days before surgery and the administration of platelet glycoprotein IIb/IIIa inhibitors. In common with previous investigators, we did not consider treatment with low-molecular-weight heparin and aspirin below the dosage of 160 mg/day to be contraindications to the procedure Patients with significant aortic insufficiency were also excluded from the study in order to avoid introducing further variables that could influence hemodynamic response to the procedure Patients were excluded if they underwent an AVR on an emergency basis, had poor acoustic windows for adequate echocardiographic assessment, and/or did not undergo an echocardiogram before the operation | 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, Hypertrophic Cardiomyopathy Adults: a wall thickness ≥15 mm in one or more LV myocardial segments-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging (CMR) or computed tomography (CT))-that is not explained solely by loading conditions Children: an LV wall thickness more than two standard deviations greater than the predicted mean (z-scored>2, where a z-score is defined as the number of standard deviations from the population mean) Relatives: the first-degree relatives of patients with unequivocal disease (LVH ≥15 mm) is based on the presence of otherwise unexplained increased LV wall thickness ≥13 mm in one or more LV myocardial segments, as measured using any cardiac imaging technique [echocardiography, cardiac magnetic resonance (CMR) or CT] Patients with severe valvular disease, aortic stenosis, congenital heart disease, hypertensive heart disease, diabetic cardiomyopathy, or other cardiovascular or systemic diseases that may cause ventricular hypertrophy Patients who had participated in any clinical trial during the first 3 months Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix) Patients refused to comply with the requirements of this study to complete the research work | 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): 21.0-65.0, CHD - Coronary Heart Disease Health Knowledge, Attitudes, Practice Health Behavior working full-time; 2. aged between 21-65 years; 3. use a smartphone (e.g. Samsung, iPhone) in their daily lives frequently; and 4. able to read, speak and understand English have a clinical diagnosis of CHD or other heart diseases (e.g. congestive heart failure); 2. work in a health-relevant school/department/environment (e.g. school of medicine, school of public health, department of dentistry, school of pharmacy; university health centre); and 3. have reading difficulties | 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): 18.0-65.0, Constipation Age between 18 and 65 years Diagnosed with chronic constipation according to Rome IV A recent history of abdominal surgery Intestinal obstruction, ileus, colon cancer Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease, Megacolon, Megarectum Umbilical hernia Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease, Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis, Cerebro-vascular event Paraplegia Mental problem to prevent co-operative treatment Pregnancy and lactation | 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 Subjects suffering from severe symptomatic aortic valve stenosis (including subjects with a bicuspid valve). 2. Patient is not eligible for TAVR/SAVR . 3. Age ≥18 years. 4. Subjects who are willing to provide a written informed consent prior to participating in the study. 5. Subjects who can comply with the study follow up or other study requirements. 6. Subject eligible according to Clinical Review Committee - Subjects with any electrical device implanted. 2. Subjects with unstable arrhythmia not controlled by medical treatment. 3. Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position. 4. Subjects with complex congenital heart disease. 5. Chest deformity. 6. Cardiogenic shock. 7. History of heart transplant. 8. Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment. 9. Thrombus in heart. 10. Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment*. 11. Subjects who are pregnant or nursing. 12. Subjects who are participating in another research study for which the primary endpoint has not been reached. - | 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): 65.0-999.0, Severe Aortic Stenosis Aortic Regurgitation Subjects ≥ 65 years of age Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s, or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of <1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular systolic dysfunction (LVEF<50%) Symptoms suggestive of aortic stenosis, NYHA class III or IV Patients who are considered unsuitable for surgery are considered by two or more than two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system estimation; or there is a severe and irreversible organ damage to the patient, such as lung disease, liver disease, kidney disease and so on; or the patient's physical weakness can not be tolerated by surgery; or have other factors affecting surgery, such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe calcification of the aorta, etc) A life expectancy of > 1 year Voluntarily participate in and sign the informed consent form and willing to undergo the related examination and clinical follow-up Untreated severe coronary stenosis and needs revascularization; or acute myocardial infarction occurred within 1 months, or coronary stent implantation in 1 month Artificial heart valve and artificial valve ring have been implanted； Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area<1.5 cm2)； left ventricular or atrial thrombus Aortic annulus diameter <17mm or >27 mm Severe left ventricular dysfunction, ejection fraction <20%； Severe pulmonary hypertension or severe right ventricular dysfunction； The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm Cerebrovascular event in last 3 months； Active endocarditis or other active infection | 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 Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of the following: 1. Aortic valve area ≤ 1.0 cm^2 or 0.6 cm^2/m^2 2. Mean aortic valve gradient ≥ 40 mmHg 3. Peak aortic valve velocity ≥ 4 m/sec Symptoms due to severe aortic stenosis resulting in one of the following: 1. NYHA Functional Classification of II or greater 2. Presence of angina 3. Presence of syncope Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging Patient is considered intermediate or high risk to undergo surgical aortic valve replacement with one of the following: 1. Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8% 2. High Surgical Risk: STS-PROM score of ≥ 8% 3. Documented heart team agreement of risk for surgical aortic valve replacement (SAVR) due to other factors not captured by risk-scores (i.e. frailty or comorbidities) Geographically available, willing to comply with follow up and able to provide written informed consent Patients with a coronary height of <10mm, or otherwise determined to be at high risk for coronary obstruction Patients with low flow/low gradient aortic stenosis Patients with significant annular or LVOT calcification that could compromise procedural success Pre-existing prosthetic heart valve in any position, or prosthetic ring Severe aortic, mitral or tricuspid valve regurgitation Untreated clinically significant coronary artery disease requiring revascularization Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification or severe tortuosity) that would preclude passage of 18 Fr catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT Need for emergent surgery or intervention other than the investigational procedure | 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): 19.0-129.0, Bicuspid Aortic Valve Age≥18 years. 2. Severe aortic stenosis with bicuspid anatomy. 3. NYHA≥2 and/or syncope and/or angina. 4. Patient judged by the Heart Team as indicated for TAVR Age <18 years 2. Asymptomatic patients 3. Pure aortic 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): 16.0-999.0, Fabry Disease Heart Diseases Genetic diagnosis of Fabry Disease and amenable mutation Clinical indication to Migalastat Signs of clinical or preclinical cardiac involvement (low T1 values with or without left ventricular hypertrophy) Age >16 Ability to give a complete informed consent (for minor patients informed consent will be given by parents) Contraindication to Migalastat (pregnancy, age <16, Glomerular Filtration Rate <30 ml/min, hypersensitivity to the active ingredient) Contraindication to CMR study (metallic fragment or foreign body, known claustrophobia, PaceMaker/Implantable Cardioverter Defibrillator not CMR conditional, electronic implant or device, eg, insulin pump or other infusion pump) | 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 I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient < 40 mmHg and stroke volume index (SVI) < 35ml/m2 I3. Left ventricular ejection fraction ≥ 50% I4. MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood are fulfilled (symptoms without other explanation and LV hypertrophy; age < 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason) I5. Heart team agrees on for TAVR I6. Written informed consent I7. Negative pregnancy test in women with childbearing potential E1. Hemodynamic instability E2. Cardiogenic shock E3. Pre-existing mechanical or bio-prosthetic valve in any position E4. Concomitant severe valvular heart disease E5. Pre-existing or active endocarditis E6. Need for heart surgery due to other conditions E7. Aortic valve is congenital unicuspid or congenital bicuspid E8. Hypertrophic cardiomyopathy with or without obstruction E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation E10. Acute myocardial infarction within 1 month before intended AS-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 Participant is willing and able to give informed consent for participation in the study Age 18 years or above Planned surgical AVR (+/ CABG or aortic root surgery) for severe AS Ability to understand the written information in English The participant may not enter the study if ANY of the following apply Contraindication to MRI (e.g., non-compatible pacemaker or other device) Severe claustrophobia (unable to have MRI scan) eGFR<30ml/min (contra-indication to have contrast agent during MRI) Contraindication to Adenosine (severe asthma) Significant arrhythmia Other valve disease > moderate in severity Female participants who are pregnant or lactating Previous aortic valve or aorta surgery, previous CABG or other surgery involving aortic cross clamping Participant in an interventional cardiovascular clinical 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, Hepatocellular Carcinoma Cirrhosis Liver Failure Have been diagnosed with HCC and deemed a candidate for nonsurgical local therapy (TACE and/or percutaneous ablation) Have a Child-Pugh score < 6 Are at least 18 years of age or older Otherwise healthy adults Provide written consent to participate Have a diagnosis of renal failure Have a Child-Pugh score > 6 Consume > 60g alcohol intake per day Have been diagnosed with branched-chain ketoaciduria (maple syrup urine disease) Have hepatic encephalopathy Have been diagnosed with a medical condition that warrants a low-protein diet Are currently taking insulin or metformin Pregnant women Younger than 18 years of age Are unable to provide 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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine 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 B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 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): 40.0-80.0, Heart Failure Essential Hypertension Moderate/severe hypertensive left ventricular (LV) hypertrophy (LVMi ≥109 g/m² in women and ≥132 g/m² in men); 2. New York Heart Association (NYHA) class II-III heart failure; 3. Left ventricular ejection fraction > 50%; 4. Increased LV filling pressures assessed at rest or at peak exercise by echocardiography 5. Body mass index (BMI) > 30 kg/m² 6. Signed and data informed consent Age ≤ 18 years; 2. Evidence of myocardial ischemia during stress echocardiography; 3. Chronic atrial flutter or atrial fibrillation; 4. Alternative cause of left ventricular hypertrophy and impaired diastolic function (hypertrophic/restictive cardiomyopathy, aortic stenosis, constrictive pericarditis and etc.); 5. NYHA classification I or decompensated heart failure at screening; 6. Systolic blood pressure < 110 mmHg or > 180 mmHg; 7. Diastolic blood pressure < 40 mmHg or > 100 mmHg; 8. Anemia (Hb < 100 g/l); 9. Significant left sided structural valve disease; 10. Secondary hypertension; 11. Dyspnea due to non-cardiac causes such as pulmonary disease, anemia, severe obesity, primary valvular, or myocardial diseases; 12. Myocardial infarction or myocardial revascularization within the last 3 months of screening; 13. Stroke or TIA within the last 3 months of screening; 14. Autoimmunic and oncological diseases; 15. Impaired renal function, defined as eGFR < 30 ml/min/1.73 m²; 16. Impaired liver function; 17. Potassium concentration >5.2 mmol/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, Pulmonary Hypertension Valvular Heart Disease Congenital Heart Disease Congestive Heart Failure Pulmonary Embolism Acute Coronary Syndrome Patient age is over 18 years Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric analysis Patient is capable of giving informed consent The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes Patient unable to under echocardiogram | 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, Tricuspid Regurgitation Age > 18 years 2. Indication left-side valve surgery Unwillingness to give informed consent and to enter a regular follow-up program. 2. Prior surgical or percutaneous mitral valve intervention 3. Contraindication to cardiopulmonary bypass (CPB) 4. Clinical signs of cardiogenic shock at the time of randomization | 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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 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): 18.0-89.0, Aortic Stenosis Mitral Regurgitation Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models) Moderate to severe mitral regurgitation Symptom status NYHA II-III Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before Age ≥ 18 and < 90 years Written informed consent MR mechanism/anatomy precluding MitraClip therapy Groin blood vessels are not eligible for TAVI procedure Massive or torrential tricuspid regurgitation Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen Life expectancy < 1 year due to non-cardiac conditions LVEF ≤ 25% Hypotension (systolic pressure < 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support Cardiomyopathy other than dilated cardiomyopathy Fixed pulmonary artery systolic pressure > 70 mm Hg Any prior mitral valve surgery or transcatheter mitral valve procedure | 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 Stenosis Coronary Artery Disease Consecutive patients with severe aortic stenosis undergoing TAVR with all commercially available devices Availability of preprocedural aortic root evaluation by computed tomography angiography scans TAVR in degenerated bioprostheses Known ostial chronic total occlusion Transcatheter valve not deployed in its anatomical position Patients with hemodynamic instability during the procedure | 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): 10.0-999.0, Aortic Valve Stenosis Aortic Stenosis Valve Stenoses, Aortic Aortic Valve Calcification Patients aged more than 10 years old Patients with aortic valve stenosis with an indication of aortic valve replacement having low to moderate surgical risk (EuroScore II <5) The patient or guardian (the research subject's parent) agrees to follow the study Patients who have previously underwent aortic valve replacement Patients with aortic stenosis due to bicuspid aortic valve Patients with autoimmune disease Patients with mixed connective tissue 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): 0.0-999.0, Aortic Stenosis Symptomatic Amyloidosis Cardiac Symptomatic, severe aortic stenosis More than mild valvular disease of any other valve Other severe disease with a life expectancy < 1 year Participating in trial interfering with routine clinical practice or use of a non-CE marked 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): 18.0-999.0, Tachycardia, Ventricular Defibrillators, Implantable Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation ICD implanted at St Olavs hospital, Trondheim In case of difficulties with patient for the study, the might be broadened to patients with idiopathic ventricular arrhythmia as cause for implantation inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk comorbidity where endurance training at more than moderate intensity is discouraged severe cardiac valve disease planned surgery within the next 3 months inability to give 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): 20.0-100.0, Bicuspid Aortic Valve Thoracic Aortic Aneurysm Aortic Dissection Bicuspid aortic Valve or Age-sex matched healthy volunteer Pregnancy eGFR < 30 previous aortic replacement surgery previous aortic valve surgery contrast allergy other reason unable to undergo 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): 18.0-65.0, Pulmonary Hypertension Severe mitral stenosis (mitral valve area ≤1.5cm) Significant dyspnea Favorable anatomical characteristics for PMC as assessed by transthoracic echocardiography Significant mitral regurgitation (≥ grade II/IV). Bilateral commissural calcification Presence of other lesions which need open heart surgery Wilkins' score > 12 Persistent LA thrombus despite adequate anticoagulation End stage renal or liver disease Patients with severe COPD and other chest problems that might be complicated by pulmonary hypertension per se | 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, Cardiogenic Shock Age ≥18 Impaired LV systolic function with ≤35% of left ventricular ejection fraction (LVEF) Enlarged LV with ≥50mm of left ventricular diastolic diameter (LVEDD) on echocardiogram Non-cardiac etiology Surgically correctable cardiac abnormality Recent significant pulmonary embolism Severe pulmonary hypertension Acute aortic dissection Presence of mechanical aortic valve prosthesis Presence of left ventricle thrombus Pre-existing Impella® 5.0 Critical aortic stenosis Uncorrectable system malperfusion under ECMO support | 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, Valve Heart Disease Aortic Stenosis Aortic Regurgitation Age 18-90 years of age Suspected moderate or severe MR,AR or AS on the basis of prior known clinical history or clinical exam Suspected CRT "non-responder" with an implanted MRI compatible CRT device and reduced ejection fraction Acute traumatic cardiac injury Aortic dissection or aortic root rupture Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD Presence of A-V fistula or intracardiac shunts Any contraindications to CMR Moderate or severe dysfunction in multiple valves Patients with significant claustrophobia | 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 Consenting patient over the age of 18 referred to CCTA for suspected coronary artery disease Inability to provide informed consent Short life expectancy (<12 months) due to non-cardiovascular 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): 0.0-999.0, Stroke Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery Subject (or legal representative) provides written informed consent Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium Subject has compromised blood flow to the right upper extremity Subject has access vessels with excessive tortuosity Subject has uncorrected bleeding disorders Subject is contraindicated for anticoagulant and antiplatelet therapy | 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, Calcific Aortic Stenosis Calcific Aortic Stenosis - Bicuspid Valve Aortic Valve Disease Aortic Valve Calcification Aortic Diseases Aortic Aneurysm Aortic Valve Cusp Abnormality Aortic Valve Disease Mixed Aortic Valve Insufficiency Patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery Age < 20 years Unable/unwilling to consent History of aortic valve replacement or transcatheter aortic valve replacement (TAVR) History of endocarditis History of rheumatic fever History of chest radiotherapy History of organ transplant | 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): 0.0-110.0, Diabetes Mellitus, Type 2 Artery Disease Protein Deposition Coronary artery bypass surgery performed at Odense University Hospital Useful sample of internal mammary artery Willingness to participate Other cardiac surgery performed Withdrawal of 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, Aortic Stenosis Patient with severe symptomatic aortic stenosis defined by a mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of <0.6 cm2/m2 Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class > I, angina or syncope) Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of a cardiologist and surgeon or as confirmed by a logistic EuroSCORE I > 20% and / or STS score > 8% OR Over 80 years old OR Over 65 years old with 1 or 2 (but not more than two) from the following Liver cirrhosis (Class A or B). Pulmonary insufficiency: VMS<1 liter. Previous heart surgery (CABG, vascular surgery). Porcelain aorta. Pulmonary artery systolic pressure >60 mmHg and high risk for heart surgery. Relapsing pulmonary embolism. Right ventricular insufficiency. Thoracic wall injuries that contraindicate an open heart surgery. History of radiation therapy of the mediastinum. Connective tissue disease that contraindicates an open heart surgery. Frailty/cachexia Aortic valve diameter of ≥20mm and ≤2 9mm as measured by echo Ascending aorta diameter ≤ 43 mm at the sinotubular junction Arterial aorto-iliac-femoral axis suitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter ≥ 6mm) Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up Patient has given written consent to participate in the trial A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin and bivalirudin, ticlodipine and clopidogrel, nitinol (titanium or nickel), contrast media Ongoing sepsis, including active endocarditis Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to Heart Team assessment Echocardiographic evidence of LV or LA thrombus Mitral or tricuspid valve insufficiency (> grade II) Previous aortic valve replacement (mechanical or bioprosthetic) Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA) Patients with: Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a transcatheter sheath. OR Symptomatic carotid or vertebral artery disease (> 70% stenosis) The patient has a bleeding diathesis, coagulopathy or denies blood transfusion Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions | 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 Heart Valve Diseases Female patients with severe aortic stenosis as follows: • High gradient severe AS (Class I Indication for aortic valve replacement [AVR]): Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg with Aortic Valve Area (AVA) ≤ 1.0 cm^2 or AVA index ≤ 0.6 cm^2/m^2 OR • Low gradient severe aortic stenosis (Class I/IIa indication of AVR) Jet velocity < 4.0 m/s and mean gradient < 40 mmHg and AVA ≤ 1.0 cm^2 and AVA index ≤ 0.6 cm^2/m^2 with confirmation of severe AS by: mean gradient ≥40 mmHg on dobutamine stress echocardiography and/or aortic valve calcium score ≥ 1200 AU on non-contrast CT. AND NYHA Functional Class ≥ II OR Exercise test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia 2. Age ≥ 18 years 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)/Ethics Committee (EC) of the respective clinical site Patient is not a candidate for both surgical and transcatheter aortic valve replacement. 2. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV based on 3D imaging analysis 3. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 4. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization 5. Aortic valve is unicuspid, bicuspid, or is non-calcified 6. Severe aortic regurgitation (>3+) 7. Any concomitant valve disease that requires an intervention 8. Pre-existing mechanical or bioprosthetic valve in any position (mitral ring is not an exclusion). 9. Complex coronary artery disease Unprotected left main coronary artery stenosis Syntax score > 32 (in the absence of prior revascularization) Heart Team assessment that optimal revascularization cannot be performed. 10. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days before randomization 11. Leukopenia (WBC < 3000 cell/mcL), anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mcL), history of bleeding diathesis or coagulopathy, or hypercoagulable states 12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days before randomization 13. Hypertrophic cardiomyopathy with obstruction 14. Ventricular dysfunction with lleft ventricular ejection fraction < 30% 15. Cardiac imaging (echo, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation 16. Inability to tolerate or condition precluding treatment with anti- thrombotic/anticoagulation therapy during or after the valve implant procedure 17. Stroke or transient ischemic attack within 90 days before randomization 18. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy 19. Active bacterial endocarditis within 180 days of randomization 20. Severe lung disease (FEV1 < 50%) or currently on home oxygen 21. Severe pulmonary hypertension (e.g., pulmonary arterial systolic pressure ≥ 2/3 systemic pressure) 22. History of cirrhosis or any active liver disease 23. Significant abdominal or thoracic aortic disease (such as porcelain aorta, aneurysm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR. 24. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or internal mammary artery to sternum, etc.) 25. Patient refuses blood products 26. BMI > 50 kg/m^2 27. Estimated life expectancy < 24 months 28. Absolute contraindications or allergy to iodinated contrast agent that cannot be adequately treated with pre-medication 29. Immobility that would prevent completion of study procedures 30. Currently participating in an investigational drug or another device study. 31. Pregnancy or lactation | 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): 21.0-64.0, Muscle Weakness Metatarsal Fracture Healing Fracture of Bone Aged over 18 years Acute (presented within one week of injury) Zone 1 fractures of fifth metatarsi Zone 2-3 fractures Diabetes mellitus Osteoporotic bone (T score<-2.5) History of osteoporotic drug therapy Other lower extremity any fracture Previous foot surgery or fracture in both lower extremity Chronic fracture, pathological fracture Aged over 65 years (congruity of muscle strength test) Open fracture | 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 Completed successful elective TAVI for severe native aortic valve stenosis with any commercially-available transcatheter heart valve (THV) Correct positioning of a single prosthetic heart valve Device success, defined by Mean aortic valve gradient < 20 mmHg Peak transvalvular velocity < 3.0 m/s Aortic valve regurgitation of 2 or less No periprocedural complications No overt stroke No uncontrolled bleeding No major vascular complication defined by the Valve academic research committee 2 (VARC-2) consensus History of life-threatening or major bleeding event ≥ Bleeding academic research committee (BARC) 3b definitions within the last year Conditions with a high risk of bleeding Active peptic ulcer or upper gastrointestinal bleeding (< 3 months) Malignancy with high risk of bleeding Recent unresolved brain of spinal injury Spinal or ophthalmic surgery within last 3 months prior to enrolment Intracranial haemorrhage Esophagal varices Arteriovenous malformations with high risk of bleeding Vascular aneurysms | 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, Pulmonary Artery Hypertension Right Ventricular Dysfunction Patients referred for a clinically indicated right heart catheterization to either diagnose pulmonary arterial hypertension prior to initiating therapies or monitor response to ongoing therapies in patients with diagnosed pulmonary arterial hypertension Patients with pulmonary arterial hypertension with or without significant right ventricular dysfunction as assessed by baseline echocardiography and standard of care right heart catheterization Functional class 2 or 3 symptoms Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements English speaking All patients will be required to have evidence of right ventricular hypertrophy or conduction delay (QRS > 130ms) on surface ECG Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators Functional class 4 symptoms Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension Contraindication to right heart catheterization including significant thrombocytopenia (platelets < 50,000), coagulopathy (INR > 1.8), or pregnancy as determined by routine screening laboratory work Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart catheterization on the day of the study procedure Pulmonary capillary wedge pressure greater than or equal to 15 mmHg as determined by the right heart catheterization on the day of the study procedure Severe tricuspid regurgitation as determined by baseline transthoracic echocardiogram Left ventricular dysfunction (EF < 50%) as determined by baseline transthoracic echocardiogram Inability to complete cardiac MRI or transthoracic echocardiography Patients with confounding systemic disease specifically portopulmonary hypertension and scleroderma associated pulmonary hypertension | 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): 18.0-60.0, Aneurysm Aortic Root Aortic Valve, Bicuspid been operated with a valve sparing root procedure in the University Hospital Ghent, Belgium, since 2000 being able to perform an exercise test on a reclining bicycle normal left ventricular function <18 years or >60 years of age peak gradient across the aortic valve at rest of >20mmHg decreased left ventricular function | 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, Systolic Heart Failure Stage D (Disorder) Mitral Regurgitation aged 18 years or older acute decompensated heart failure due to severe left ventricular systolic dysfunction combined with hemodynamically significant mitral regurgitation. Severe systolic dysfunction and hemodynamically significant mitral regurgitation are defined as left ventricular ejection fraction less than 35% and mitral regurgitant volume more than 45 ml (more than moderate degree), respectively cancer or other significant co-morbid diseases with expected life span less than 3 years adverse effects of hydralazine surgical interventions of mitral regurgitation will be done in follow-up period which change the course of native condition other valvular conditions other than mitral regurgitation with severity more than or equal to moderate degree, particularly mitral stenosis, and aortic regurgitation/stenosis lack of written informed consent | 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 Mitral Valve Disease Tricuspid Valve Disease Aorta Disease Coronary Artery Bypass Graft EuroSCORE II ≥ 3% or EuroSCORE logistic of ≥ 6% Patients undergoing routine/ urgent cardiac surgery Patients must have the ability to provide informed consent Patients undergoing salvage or emergency operations | 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, Calcific Patients must have severe degenerative high flow AS (echocardiographic aortic valve (AV) effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s) in presence of normal ejection fraction (EF). 2 Patients must be symptomatic from the AS (dyspnea in NYHA-class II or greater, angina pectoris, or syncope), or asymptomatic but with decreased left ventricular ejection fraction, positive stress test , Pulmonary hypertension (systolic pulmonary artery pressure >60 mmHg). 4-Symptomatic patients with severe low-flow, low-gradient (<40 mmHg) aortic stenosis with reduced ejection fraction and evidence of flow (contractile) reserve. 3 Patients surviveal time more than one year . 4 Patients have contraindications for open chest surgery, such as : 1. Presence of comorbidities not adequately reflected by risk scores. 2. Procelain aorta 3. Squelae of chest radiation. 4. Severe chest deformation or scoliosis. 5. Previous cardiac surgery Evidence of an acute myocardial infarction 30 days before the intended treatment. 2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified. 3. Mixed aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+). 4. Hemodynamic or respiratory instability within 30 days of screening evaluation. 5. Need for emergency surgery for any reason. 6. Hypertrophic cardiomyopathy with or without obstruction. 7. Severe left ventricular dysfunction with LVEF <20%. 8. Severe pulmonary hypertension and RV dysfunction. 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. . 10-A known contraindication to all anticoagulation regimens, or inability to be anticoagulated for the study procedure. 11-MRI confirmed stroke or transient ischemic attack within 6 months (180 days) of the procedure. 12-Renal insufficiency (creatinine >3mg) and / or end stage renal insufficiency requiring chronic dialysis at the time of screening. 13-Estimated life expectancy<12 month. . 14-Severe incapacitating dementia 15-Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5 mm), protruding or ulcerated] or narrowing of the abdominal or thoracic aorta, severe tortuosity of the thoracic aorta. Also a minimum iliac or femoral artery diameter of less than 6 mm may be deemed unsuitable for femoral approach. 16-Severe mitral regurgitation. 17-Annulus size out of range of available prosthese (<18mm and >29mm). 18-Untreated coronary artery disease requiring revascularization. 19 Elevated risk of coronary ostium obstruction (asymmetric valve calcification, short distance between annulus and coronary ostium less than 10mm | 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, Mitral Valve Insufficiency Coronary Stenosis Mitral Regurgitation Coronary Artery Disease Age ≥18 years; 2. Patients with significant degenerative or functional MR planned for TMVR with the percutaneous edge-to-edge mitral valve repair MitraClip system; 3. Patients with ≥ 1 coronary artery lesion with angiographically-documented ≥50% diameter stenosis, 4. Patient willing and able to provide written informed consent Previous coronary artery bypass surgery; 2. Presence of ≥1 coronary total occlusion(s); 3. Documented non-viable myocardium in the area of the corresponding coronary artery being studied; 4. Severe left ventricular systolic dysfunction (<30%); 5. Cardiogenic shock/hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg) and/or need for mechanical/pharmacologic hemodynamic support; 6. Systolic pulmonary artery pressure > 70 mmHg on baseline echocardiography; 7. Significant contraindication to adenosine administration (e.g. heart block, severe asthma); 8. Extremely calcified or tortuous vessels precluding invasive coronary physiology measurement; 9. Acute coronary syndrome with recent ST-elevation myocardial infarction <5 days prior to randomization, or ongoing non-ST elevation acute coronary syndrome with biomarkers (cardiac troponin) still rising; 10. Hypertrophic cardiomyopathy, restrictive pericarditis, constrictive pericarditis, infiltrative cardiomyopathy; 11. Participation or planned participation in another clinical trial, except for observational registries; 12. Patients unable or unwilling to provide written informed consent | 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): 45.0-85.0, Coronary Artery Disease Patients aged 45-85 years with history of CHD will be asked to participate. History of CHD is defined as prior documentation of a coronary artery stenosis of 50% or greater by coronary angiography or by prior documentation of coronary artery revascularization by percutaneous coronary intervention (PCI). Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA Suspected obstructive coronary artery stenosis based on clinical history and/or noninvasive testing, prompting a clinical referral for invasive coronary angiography; and/or planned PCI within the next 60 days Ability to understand and willingness to sign the Informed Consent Form Known allergy to iodinated contrast media History of multiple myeloma or previous organ transplantation Elevated serum creatinine (> 1.5mg/dl) or calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block) Evidence of severe symptomatic heart failure (NYHA Class III or IV) Known or suspected moderate or severe aortic stenosis Previous coronary artery bypass or other cardiac surgery Suspected acute coronary syndrome Presence of any other history or condition that the investigator feels would be problematic | 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 Disease Patients with severe symptomatic aortic valve lesion. 2. Asymptomatic aortic insufficiency patients with left ventricular dysfunction or significant left ventricular dilatation (LV end diastolic diameter>70 mm or LV end systolic diameter>50 mm. 3. Patients with aortic regurgitation caused by a dilated aortic annulus conjoined cusp prolapse in bicuspid aortic valves (BAV) single cusp prolapse in tricuspid aortic valves aortic valve cusp perforation from endocarditis Patients with previous aortic root or valve surgery | 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, Transcatheter Aortic Valve Replacement Hemodynamic Monitoring Aortic Valve Insufficiency Aortic Valve Stenosis Patients must be >18 years old. 2. Written informed consent is obtained from all patients. 3. Severe aortic valve stenosis is defined as: jet velocity greater than 4.0m/s or Doppler Velocity index <0.25 or an initial aortic valve area (AVA) of ≤ 1.0cm² (indexed EOA≤06 cm²/m²) as measured by trans thoracic echocardiography <6months prior to inclusion. 4. Patients have symptomatic aortic stenosis, as demonstrated by New York Heart Association (NYHA) functional class 2 or greater or other symptoms of aortic stenosis (e.g. syncope or angina in the absence of coronary artery disease). 5. Surgical risk is deemed high or intermediate by Society of Thoracic Surgery (STS) risk score or by documented Heart-team agreement due to frailty or co-morbidities. 6. The aortic annulus diameter as measured by ECG-triggered CT-scanning < 6months prior to meets the ranges indicated in the instructions for use. 7. The access artery diameters (femoral or subclavian) as measured by CT-scanning < 6 months prior to meet the ranges indicated in the instruction for use. 8. There are no contra-indications (e.g.: severe claustrophobia, metal implants, severe renal failure) for and patient is willing to undergo cardiac MRI at discharge to 30 days after TAVI Patient is unwilling or unable to comply with study-required follow-up evaluations. 2. There is evidence of a myocardial infarction within 30 days to index procedure. 3. The presence of severe mitral regurgitation or stenosis. 4. The presence of pre-existing prosthetic cardiac device, valve or prosthetic ring in any position. 5. Left ventricular ejection fraction (LVEF) less than 30%. 6. Untreated significant coronary artery disease requiring revascularization. 7. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation suggesting active endocarditis. 8. The patient is hemodynamically unstable, requiring inotropic or vasopressive and / or mechanical support. 9. The presence of pulmonary edema or intra venous diuretics to stabilize heart failure at index procedure. 10. Renal insufficiency, defined as a serum creatinin greater than 250umol/l or end-stage renal disease requiring dialysis. 11. Morbid obesity, defined as a BMI ≥40. 12. A life expectancy of less than one year | 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): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 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): 45.0-80.0, Albuminuria Age 45 to 80 years Living in the municipality of Breda, The Netherlands Not institutionalised Younger than 45 years or older than 80 years Not living in the municipality of Breda, The Netherlands Institutionalised. A random sample of 15.032 subjects will be drawn from the population aged 45-80 years from the municipality of Breda by the Dutch Central Bureau for Statistics (CBS) | 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): 14.0-100.0, Takayasu Arteritis Methotrexate Inhibition Treatment age≥14 years; 2. active status: Kerr score≥ 2; 3. mild and moderate: 1. Blood pressure (maximum) < 180/110mmHg; 2. 1-2 branches with the stenotic rate < 70% involved; 3. mildly ischemic manifestation relative to activity but relieve after rest; 4. no or low degree of organ insufficiency: NYHF I~II; eGFR (MRDR) ≥ 60ml/min Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease; 4. malignant tumors; 5. history of severe drug allergy; 6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients) | 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): 14.0-100.0, Takayasu Arteritis Tocilizumab Adalimumab Treatment age≥14 years old; 2. active: Kerr score≥ 2; 3. severe: 1. Blood pressure > 180/110mmHg; 2. ≥ 3 branches with the stenotic rate > 70% involved; 3. high degree of organ insufficiency: NYHF III~IV; eGFR (MRDR) 15~ 60ml/min Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease; 4. malignant tumors; 5. history of severe drug allergy; 6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients) | 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): 50.0-80.0, Osteoarthritis, Hip Age 50-80 Continuous worsening of hip pain with an onset of minimum 3 months Hip Pain intensity >40mm on a visual analogue scale (VAS) ranging from 0 (no pain) to 100mm (maximal pain) during weight bearing for the last 7 days HHS < 65 (Harris Hip Score) Hip OA fulfilling the ACR (American College of Rheumatology) [33] Hip MRI scan showing large (>1 cm diameter) Bone Marrow lesions (BMLs) Willing and able to consent and comply with the study protocol eGFR (estimated glomerular filtration rate) < 35 ml/min or hypocalcemia Exposure to any treatment affecting bone other than Ca+D ( bisphosphonates, Denosumab teriparatide or continuous treatment of prednisolone) Diseases affecting bone and joints (i.e inflammatory joint diseases, osteonecrosis with segmental collapse and deformation, primary bone cancer or known skeletal metastases) Severe vitamin D deficiency (S-25(OH)D < 25 nmol/l) has to be supplemented with Ca+D before zoledronic acid infusion Ipsilateral knee prosthesis Contralateral hip prosthesis Women of child bearing potential (WOCBP). Female participants must be in a postmenopausal state or permanent sterile Hypersensitivity or previous allergic reaction to ZA or other bisphosphonates Hypersensitivity or previous allergic reaction to Calcigran Forte (a calcium and vitamine D supplement) or Prednisolone | 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 Coronary Artery Disease TAVI PCI Age ≥18 years Patients with severe aortic stenosis and concomitant coronary artery disease accepted for TAVI and PCI by a multidisciplinary Heart Team Severe symptomatic aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or ≥40 mmHg (echocardiography) and at least one of the following: 1. Dyspnea 2. Angina symptoms 3. Syncope 4. Decline in left ventricular ejection fraction <50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk (peak transaortic velocity >5.5 m/s, severe valve calcification, peak transaortic velocity progression ≥0.3 m/s per year, and severe pulmonary hypertension with systolic pulmonary artery pressure >60 mmHg) according to current guidelines Inability to give informed consent No PCI-eligible coronary artery stenosis Admission with acute coronary syndromes within 30 days before randomization Previous coronary artery bypass grafting (CABG) Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel) Planned cardiac or major surgery Known pregnancy at the time of Participation in another clinical study with an investigational product Life expectancy <1 year due to other severe non-cardiac 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): 60.0-87.0, Calcific Aortic Valve Disease Aortic Valve Stenosis Aortic Valve, Calcification of Retrospective cohort: patients with severe aortic valve stenosis in echocardiography: • Vmax > 4 m/sec and mean Gradient >40 mmHg and/or Aortic Valve Area indexed (AVAi) < 0.6 cm2/m2 and/or Velocity index <0.25 whichever worse, with available complete past echocardiographic follow-up (>2 past studies) indicating disease progression, by the same performing physician Prospective cohort: patients with moderate aortic valve stenosis in echocardiography Vmax 3-4 m/sec and mean Gradient 25-40 mmHg and/or AVAi 0.6-0.9 cm2/m2 Where inconsistent: Velocity index = 0.25-0.50 Technical details: Optimal doppler measurements obtained by the best feasible echocardiographic window (demonstrating at least 2 windows, where possible including right parasternal with or without pencil probe) Prospective Control group: patients at intermediate to high risk for CVD according to atherosclerotic risk factors assessment Heart Score Echocardiographic Stroke Volume indexed (SVi) <35 ml/m2 Bicuspid aortic valve Stenosis of rheumatic etiology More than mild aortic valve regurgitation More than mild mitral valve regurgitation More than mild mitral stenosis Severe pulmonary hypertension Chronic ischemic heart failure with Ejection Fraction < 45% Right heart failure (based on the echocardiographic assessment of Right Ventricle Dimension, Tricuspid Annular Plane Systolic Excursion, tricuspid annular velocity, and clinical syndrome) Acutely decompensated Heart Failure with preserved Ejection Fraction <4 weeks | 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 Age ≥ 18 years Patients with severe AS defined by an AVA <1cm2 or AVA indexed to BSA of <0.6 cm2/m2, including low-flow severe aortic stenosis defined by SVI <35ml/m2 Life expectancy <1 year irrespective of severe AS Severe dementia defined as MMS-Test <16 points | 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): 18.0-90.0, Aortic Calcification Valve Aortic Valve Stenosis Patients who are candidates for aortic valve replacement. 2. Age greater than or equal to 18 years of age. 3. Both genders. 4. With any associated comorbidity 5. Any etiology 6. Hospitalized and with an echocardiographic study showing the variables to be studied 7. Informed Consent Patients who have previously undergone other aortic valve surgery 2. Patients who have received contrast medium ≤24 hours. 3. Patients on hemodialysis. 4. Patients with infection. 5. Patients with cancer. 6. Patients with autoimmune diseases. 7. Pregnant women. 8. Patients who refuse to be included | 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): 45.0-75.0, Ascending Aorta Aneurysm Dilation of the Ascending Aorta Extension of the ascending aorta less than 55 mm 2. Tricuspid Aortic Valves. 3. Extension of the ascending aorta more than 45 mm Age less 45 years 2. Age more 75 years 3. Multiple organ failure 4. oncological 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): 0.0-999.0, Aortic Valve Stenosis Coronary Artery Disease All patients that underwent a TAVI procedure at Örebro University Hospital between 2009 till 1st december 2019 Patients with procedural-related coronary artery injury and patients with solitary stenosis in a diagonal branch were excluded from 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): 18.0-70.0, COVID-19 Adult SARI patients with 2019-ncov infection confirmed by PCR; Absolute value of lymphocytes < 0. 6x 109/L; Severe respiratory failure within 48 hours and requires admission to ICU. (severe respiratory failure was defined as PaO2/FiO2 < 200 mmHg and was supported by positive pressure mechanical ventilation (including non-invasive and invasive mechanical ventilation, PEEP>=5cmH2O)) Age < 18 Pregnant Allergic to experimental drugs and patients have the following conditions: 1. Hypercholesterolemia 2. Hypertriglyceridemia 3. Liver disease 4. Renal disease 5. Sjögren syndrome 6. Pregnancy 7. Lactation 8. Depressive disorder 9. Body mass index less than 18 points or higher than 25 points 10. Contraindications for hormonal contraception or intrauterine device. 11. Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell transplantation 12. Patients receiving anti-hcv treatment 13. Permanent blindness in one eye 14. History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of retinal detachment or eye surgery 15. The competent physician considered it inappropriate to participate in the study 16. HIV infection or other immunodeficiency or with an absolute neutrophil count ≤1.0 × 109/L 17. Abnormal liver biochemistry (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase) >1.5 × upper limit of normal or total bilirubin > upper limit of normal (unless Gilbert's disease with normal conjugated bilirubin) 18. Any of the following laboratory abnormalities are present at baseline Platelet count <150×109/L Serum albumin ≤ 3.5 g/dL INR ≥1.2 CPK ≥ ULN. 19. Significant liver fibrosis as evidenced by Fibrosis-4 (FIB-4) score >3.25 20. History of hypersensitivity to retinoic acid or any of its excipients or the class of neutrophil elastase inhibitors Known hypersensitivity to medications used in the study procedures (e.g. midazolam, fentanyl, and lidocaine for bronchoscopy) | 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, Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Elective CABG or AVR or MVR surgery No previous CABG or valve surgery Isolated / multivessel CABG Current neurological disorders Previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise Significant limiting comorbidities that would prevent full participation | 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, Pulmonary Arterial Hypertension Subjects aged between 18-75 years old 2. PAH which is idiopathic, heritable or associated with anorexigens 3. Subjects willing to be genotyped for genes that influence PDGF activity 4. Resting mean pulmonary artery pressure ≥25 mmHg, Pulmonary capillary wedge pressure ≤15 mmHg, PVR >5 wood units, and normal or reduced cardiac output , as measured by right heart catheterisation (RHC) at entry 5. Six-minute walking distance >50m at entry 6. Stable on an unchanged PAH therapeutic regime comprising at least 2 therapies licensed for PAH (any combination of endothelin receptor antagonist, phosphodiesterase inhibitor or prostacyclin analogue) for at least 1 month prior to screening 7. Able to provide written informed consent prior to any study mandated procedures 8. Contraception: Fertile females (women of childbearing potential) are eligible to participate after a negative highly sensitive pregnancy test, if they are taking a highly effective method of contraception during treatment and until the end of relevant systemic exposure. Fertile males who make use of condom and contraception methods during treatment and until the end of relevant systemic exposure in women of childbearing potential -full details are in included in the research protocol- Unable to provide informed consent and/or are non-fluent speakers of the English language 2. Hypersensitivity to Imatinib or to any of the excipients 3. Clinically-significant renal disease (confirmed by creatinine clearance <30 ml/min per 1.73m2) 4. Clinically-significant liver disease (confirmed by serum transaminases >3 times than upper normal limit) 5. Patients receiving oral and/or parenteral anticoagulants 6. Anaemia confirmed by haemoglobin concentration <10 g/dl 7. History of thrombocytopenia 8. Individuals known to have haemoglobinopathy sickle cell disease, thalassaemia 9. Hospital admission related to PAH or change in PAH therapy within 3 months prior to screening 10. History of left-sided heart disease and/or clinically significant cardiac disease, including but not limited to any of the following: 1. Aortic or mitral valve disease (stenosis or regurgitation) defined as greater than mild aortic insufficiency, mild aortic stenosis, mild mitral stenosis, moderate mitral regurgitation 2. Mechanical or bioprosthetic cardiac valve 3. Pericardial constriction, effusion with tamponade physiology, or abnormal left atrial size. 4. Restrictive or congestive cardiomyopathy 5. Left ventricular ejection fraction ≤50% (measured in echocardiogram at screening) 6. Symptomatic coronary disease 7. Significant (2+ for regurgitation) valvular disease other than tricuspid or pulmonary regurgitation 8. Acutely decompensated left heart failure within 1 month of screening 9. History of untreated obstructive sleep apnoea 11. Evidence of significant lung disease on high-resolution CT (if available) or recent (performed within 12 months) lung function, where FEV1 < 50% predicted and FVC < 70% predicted, and DLCO (or TLCO) < 50% predicted if any CT abnormalities; judged by the Site Physician 12. Patients with a history of uncontrolled systemic hypertension 13. Acute infection (including eye, dental, and skin infections) 14. Chronic inflammatory disease including HIV, and Hepatitis B 15. Women of childbearing potential who are pregnant or breastfeeding (if applicable) 16. Previous intracerebral haemorrhage 17. Patients who have received an Investigational Medicinal Product (IMP) within 5 half-lives of the last dose of the IMP or 1 month (whichever is greater) before the baseline visit | 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 Stenosis Hypertension Hemodynamically severe aortic stenosis and symptoms 2. A decision of TAVI by Heart team 3. Patients undergoing TAVI (transcatheter aortic valve implantation) 4. Life expectancy > 1-2 years Sever frailty 2. Severly reduced cognitive function 3. Multiple comorbid conditions 4. Technically not suited for TAVI | 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): 45.0-75.0, Management/Treatment of Coronary Artery Disease male and female subjects 2. aged 45-75 years 3. caucasian population 4. submitted to CCTA for suspected CHD between 2009 and 2012 (in the context of and ARTreat FPVII studies) at the Hospitals reported in "SMARTool Clinical Center" document and satisfying the elegibility reported above 5. submitted to clinical Follow-up in the last 6 months with stable clinical conditions and documented CHD or persistent intermediate/high probability of CHD 6. Signed informed consents (clinical and genetic) Multi-vessel severe disease (3 vessels and/or LM disease with >90% stenosis). 2. Severe coronary calcification (CAC score > 600). 3. Having undergone surgical procedures related to heart diseases (CABG, valve replacement, CRT or CRTD treatment, any surgery of the heart or arteries). 4. Documented MACE at history (myocardial infarction, severe heart failure, recurrent angina) in the last 6 months with/without revascularization 5. Documented severe peripheral vascular disease (carotid, femoral) 6. Surgery of carotid and/or peripheral arteries or cerebral ischemic attack 7. History/surgery of Abdominal Aortic Aneurysm(AAA). 8. Severe Heart failure (NYHA Class III-IV) 9. LV dysfunction (left ventricle EF <40%). 10. Atrial fibrillation. 11. Lack of written informed consent (clinical consent and/or genetic consent) 12. Pregnancy (evaluated by urine test) and breastfeeding 13. Active Cancer 14. Asthma 15. Severe untreated Hypertension (arterial blood pressure ≥ 170/110 mmHg) 16. Cardiomyopathy or congenital heart disease 17. Significant valvular disease (hemodynamically significant valvular stenosis or insufficiency by echoDoppler) 18. Renal dysfunction (creatinine > 1.3 mg/dL) 19. Chronic Kidney Disease (eGFR < 30 ml/min/1.73 m2) 20. Hepatic failure (at least 3 of the following: albumin < 3.5 g/dL; prolonged prothrombin time-PT; jaundice; ascites) 21. Waldenstrom disease 22. Multiple myeloma 23. Autoimmune/Acute inflammatory disease 24. Previous severe adverse reaction to iodine contrast agent 25. Positivity at blood tests for HIV, Hepatitis B and C (CRF number 1-clinical evaluation) - | 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): 45.0-999.0, Cardiac Amyloidosis Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram 2. Age equal or greater than 45 years 3. Current residency in Martinique, Guadeloupe or French Guyana 4. Ability to receive and understand research information 5. Ability to freely deliver informed written consent Pregnant or breastfeeding woman 2. Severe uncontrolled hypertension 3. Chronic hemodialysis 4. Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty | 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): 40.0-999.0, COPD Emphysema Right Heart Dysfunction At least 40 years A smoking history Smoking cessation ≥ 6 months FEV1/FVC ≤ 0,7 Severe emphysema (destruction ≥ 50%) Peak tricuspid regurgitation velocity < 2,8 m/s or presence of other echocardiographic "PH signs" ≤ FEV1post ≤ 50% Residual volume ≥ 175% predicted TLC ≥ 100% predicted Optimal medical management ≥2 hospitalizations/year for Recent (≤ 3months) ≥ 50ml mucus/day PAPm ≥35mmHg PaCO2 ≥ 55mmHg Bubble ≥ 1/3 hemithorax Lung fibrosis, bronchiectasis, lung cancer, homolateral surgery Left ventricular ejection fraction ≤ 45%, unstable heart disease Life expectancy ≤ 1 year Contraindication to anesthesia | 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 Bicuspid Cardiac Valve Cohort A: 1. Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve 2. Patients with a severely calcified aortic valve (Agatston score > 3000 for men, and > 1600 for women) 3. Patients with small anatomy defined by mean aortic annulus diameter < 20mm Cohort B: 1. every patient accepted for TAVI and eligible for Acurate TM and Lotus Edge valve TM poor CT quality previous aortic valve replacement Permanent pacemaker at baseline | 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): 50.0-999.0, Aortic Valve Stenosis Age ≥ 50 years Moderate aortic stenosis confirmed in the past 3 months by standard echocardiographic evaluation: aortic valve area >1.0 cm2 plus either maximal velocity 3.0-3.9 m/s or mean gradient 20-39 mmHg Ability to undergo exercise stress testing Ability to understand and the willingness to provide written informed consent A potential subject who meets any of the following will be excluded from participation in this study Any hemodynamic criterion for severe AS: maximal velocity >= 4 m/s, mean gradient >= 40mmHg, aortic valve area =< 1 cm2 Percutaneous coronary intervention or coronary artery bypass grafting in the past three months, or have revascularization planned in the near future Known, unrevascularized, and severe coronary artery disease (for example a 90% diameter stenosis or FFR<0.7 in the proximal left anterior descending artery) Impaired left ventricular function (ejection fraction <50%) Unicuspid, bicuspid, or non-calcified aortic valve observed during echocardiography (note that later cusp fusion noted during study-related cardiac imaging will not a subject) Severe aortic regurgitation, mitral valve disease, tricuspid regurgitation, or a significant intracardiac shunt Co-existing hypertrophic cardiomyopathy or severe septal hypertrophy >15mm Persistent atrial fibrillation with uncontrolled ventricular response Recent (within 6 weeks) acute coronary syndrome | 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 Stroke At least 18 years old Primary diagnosis of an acute or hemorrhagic stroke Admitted into the acute or acute rehab setting and is appropriate for physical therapy services Can ambulate with 1 person assistance and a device as needed, with no more than maximal assistance required. The patient must be able to independently advance the lower extremity forward, but can receive maximal assistance for blocking, bracing or postural control during ambulation Can stand and/or ambulate for at least 6 minutes Hemodynamically unstable Unstable medical co-morbidities such as: active bleeding, recurring seizures, uncontrolled hypertension (permissive HTN orders ok) Patients with bilateral acute stroke Patients who are unable to follow 1 step commands as determined by the screening physiatrist Orthopedic co-morbidities that place a weight-bearing restriction on the lower extremities such as acute fracture, joint replacement, or other musculoskeletal injury Any other condition that would limit a patient's ability to remain in a standing position with assistance for 6 minutes at a time | 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, Transcatheter Aortic Valve Replacement Age 75-79 2. Subject must have Society of Thoracic Surgeons (STS) score >=4% and <=8% 3. Subject must have at least one from the risk factors presented below: i. Severely atherosclerotic or porcelain aorta ii. Internal Mammary Artery (IMA) or other conduit(s) crossing midline and/or adherent to posterior table of sternum iii. Pre-existing mechanical valve in any other position iv. Severe right ventricular dysfunction v. Hostile chest (abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities, evidence of severe radiation damage, history of multiple recurrent pleural effusions causing internal adhesions) vi. Severe liver disease/cirrhosis vii. Frailty viii. Malignancy with life expectancy that exceeds 24 months ix. Renal replacement therapy with creatinine levels >200mmol/L or 2.26 mg/dl 4. Heart team consisting of at least one interventional cardiologist and one cardiac surgeon agree on indication and treatment proposal, based on their clinical judgment (including anatomy assessment, risk factors, etc) 5. Critical aortic valve area defined as an initial aortic valve area of <=1cm2 or aortic valve index <0.6cm2/m2 6. In presence of normal left ventricular function: 1. Mean gradient >40mmHg OR Vmax>4m/sec OR 2. In presence of low flow, low gradient severe AS, a dobutamine stress echo must be conducted that demonstrates presence of contractile reserve defined as follows >=20% increase in stroke volume and mean gradient >40mmHg 7. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater 8. The subject is suitable for direct TAVI not preceded by balloon valvuloplasty according to the judgment of the treating physicians 9. The subject and the treating physician agree that the subject will return for all required post procedure follow-up visits Hypersensitivity or contraindication to aspirin, heparin, clopidogrel, coumadin, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated; 2. Blood dyscrasias as defined: leukopenia (WBC<1000/mm3), thrombocytopenia (platelet count <50.000cells/mm3), history of bleeding diathesis or coagulopathy; 3. Ongoing sepsis, including active endocarditis 4. Any condition considered a contraindication to extracorporeal assistance; 5. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks prior treatment 6. Cardiogenic shock manifested by low cardiac output, vasopressor dependence or mechanical hemodynamic support; 7. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 8. Active gastrointestinal (GI) bleeding within the past 3 months 9. Subject refuses a blood transfusion; 10. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits); 11. Multivessel coronary artery disease with a Syntax score >22 12. Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions 13. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consentor adherence to the protocol required follow-up exams; 14. Currently participating in an investigational drug or another device trial (excluding registries) 15. Evidence of an acute myocardial infarction <=30 days before the index procedure 16. Need for emergency surgery for any reason 17. Uncontrolled atrial fibrillation Anatomical Native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging; 19. Mixed aortic valve disease [aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+] 20. Severe mitral or severe tricuspid regurgitation 21. Severe mitral stenosis; 22. Hypertrophic obstructive cardiomyopathy 23. Echocardiographic or Multislice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus or vegetation 24. Anatomy of the aortic root and ascending aorta not suitable for TAVI with Evolut R or Evolut Pro system (aortic root angulation >70 degrees for femoral and left subclavian access or >30 degrees for right subclavian access) 25. Congenital bicuspid or unicuspid valve verified by echocardiography Vascular 26. Transarterial access not able to accommodate an 16 French sheath | 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): 19.0-999.0, CAVD Male and female aged 19 years or older 2. Subjects who were diagnosed with type 2 diabetes mellitus and being treated with oral hypoglycemic drugs 3. Subjects whose Doppler echocardiography or Heart CT performed within 8 weeks prior to or during Screening Visit (Visit 1) is satisfying any of the followings Doppler echocardiogrphy (aortic valve calcification and/or hypertrophy with aortic peak velocity≥2.0 m/s); or Heart CT (aortic valve calcium score≥300 AU) 4. Subjects who decided to take part in this study on his/her own volition after listening to the details of this study Subjects with severe aortic valve stenosis (aortic peak velocity>4.0 m/s, mean pressure gradient >40 mmHg, or aortic valve area≤0.75 cm2) 2. Subjects with left ventricular ejection fraction < 40% 3. Heart failure patients: Subjects with heart failure of NYHA functional class II-IV 4. Subjects with an estimated glomerular filtration rate (eGFR) of <30ml 5. Subjects with type 1 diabetes or diabetic ketoacidosis 6. Subjects with serious hypersensitivity to DPP-4 inhibitors 7. Subjects who have received/are receiving any of the following medication therapies Vitamin K Calcium supplement (or osteoporosis medication) 8. Subjects whose aortic valve stenosis is not caused by degenerative or bicuspid valve disease (e.g. rheumatic valve disease) 9. Subjects who have received or are expected to receive (as of Visit 1) aortic valve surgery during the study. 10. Subjects for whom a two-year clinical course investigation is not possible due to malignant tumor or cerebrovascular disease 11. Pregnant or lactating women 12. Women of childbearing potential who are sexually active and do not agree to use proper contraception during the study Proper contraception means physical barrier method including condom, contraceptive diaphragm or cervix cap. The use of contraceptive or oral contraceptive containing hormones that may induce drug-drug interaction with the investigational product is not allowed during the study (with the exception of an oral contraceptive administered to cure menopausal symptoms, only if the dosage has been consistent for the past 8 weeks) 13. Any other subjects deemed not eligible for this study by an 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): 18.0-999.0, Valvular Disease Valvular Heart Disease Aortic Valve Stenosis Mitral Insufficiency and Aortic Stenosis Mitral Stenosis Coronary Artery Disease Chronic Kidney Diseases Valvular heart disease in moderate and severe stages Age < 18 years old | 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): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours | 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): 19.0-99.0, Severe Aortic Stenosis or Severe Aortic Regurgitation Age ≥ 19 yrs Severe aortic stenosis or severe aortic regurgitation Agree to consent for self Can follow-up for the next 2 years Pre-existing acute kidney injury Pre-existing end stage kidney disease: estimated glomerular filtration rate (eGFR) ≤15 ml/min/1.73m2 or receiving renal replacement therapy On ECMO or IABP Life expectancy < 12 months Pregnancy | 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, Covid19 ARDS Pneumonia, Viral Computed Tomography Patients who go to the emergency department meet the for a suspected, probable, or confirmed case of COVID-19 infection Patients who have undergone a simple chest tomography during their stay in the INC Emergency Department Patients whose information and data availability can be obtained through the triage's electronic clinical record carried out in the emergency department and coronary unit Patients with clinical data, laboratory data, oxygen saturation, and inspired oxygen fraction are necessary to evaluate prognostic indices Test for SARS-CoV2 infection by RT-PCR reported as positive, negative, or not performed, but with suspicion of COVID-19 Patients who have had an arterial blood gas Patients with incomplete clinical, laboratory, blood gas parameters Patients in whom saturation and initial FiO2 are not reported Patients referred to another Hospital during their initial evaluation | 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): 18.0-115.0, Transcatheter Aortic Valve Implantation (TAVI) Retrospective phase Consecutive, severe symptomatic aortic stenosis patients who underwent transcatheter aortic valve implantation with a balloon-expandable transcatheter aortic valve prior to the center education on QoC (Quality of Care) improvement measure (prior to the first education call)) Patient is or was scheduled to undergo a 30 Day and 12 Months follow-up (30 Day and 12 Months follow-up: hospital visit or phone call) All patients irrespective of valve type or access route will be documented in an electronic Case Report Form (eCRF) based patient logbook. Prospective phase Consecutive patients with a diagnosis of severe symptomatic aortic stenosis admitted for TAVI with a balloon-expandable transcatheter heart valve after center education on Quality of Care measures and after the center has passed the implementation phase All patients irrespective of valve type or access route will be documented in an eCRF based patient logbook Retrospective phase Patients with largely incomplete data with respect to the aims of the project Patients without signed informed consent / data protection statement (according to requirements of local ethical committee) Pregnant women at the time of the TAVI. Prospective phase Patients without signed informed consent prior to the TAVI procedure (data protection statement included; ideally covered by hospital routine to enable consecutiveness) Pregnant women at the time of the TAVI | 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, Critical Illness Diastolic Dysfunction Diastolic Heart Failure Weaning Failure Mechanical Ventilation Complication Expected to be ventilated for >48 hours Age > 50 Atrial fibrillation (at the admission or during ICU stay) Neuromuscular disorders Home ventilation prior to admission Palliative intubation Intubation for an indication to tracheostomy Poor acoustic window (after the first assessment) Severe mitral and/or aortic valve stenosis or regurgitation | 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 aortic valve stenosis treatment via TAVI | 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, Acute Coronary Syndrome hospitalised for STEMI or non-STEMI, as defined by the 4th universal definition of MI underwent coronary angiography during the index hospitalisation showing at least one epicardial coronary artery with ≥50% stenosis and a 2nd epicardial coronary artery with ≥20% stenosis on the coronary angiogram Body Mass Index (BMI) ≥18 to ≤35 kg/m2 White Blood Cell count ≥ 8.2 X 103/uL during admission Prior coronary artery bypass grafting (CABG) CABG planned within 12 months of admission Known history of drug or alcohol abuse within 5 years of screening History of QT prolongation associated with other medications that required discontinuation of that medication Congenital long QT syndrome Systolic blood pressure persistently <90 mm Hg or HR<40 beats per minute at time of enrolment ALT >2 x ULN, cirrhosis, recent hepatitis, or positive screening test for hepatitis B (hepatitis B surface antigen) or other viral hepatitis Uncontrolled Type 1 or Type 2 DM defined as HbA1c >10% or 74.9 mmol/mol (by IFCC) Any planned coronary revascularisation, valve surgery, or cardiac resynchronisation within 7 months after randomisation Any concomitant medications known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4) | 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 Non-Sustained VT Heart Failure Patients with symptomatic severe aortic stenosis referred for surgical or transcatheter AVR (one out of: effective orifice area [EOA] <1.0 cm2 , indexed EOA of 0.6cm/m2, peak velocity >4.0 m/s or mean gradient >40mmHg) More than moderate valve disease other than AS Diagnosis of dilated or hypertrophic cardiomyopathy, pregnancy/breast feeding eGFR <30ml/min, CMR incompatible devices Inability to complete the protocol Other conditions that would prevent participation in the study Adenosine perfusion will not be performed in patients with AV block, severe asthma/COPD or LVEF<40% | 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 Stenosis Coronary Artery Disease Coronary Stenosis Men and women with severe symptomatic aortic valve stenosis defined as: [aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2] AND [Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg] AND [NYHA Functional Class ≥ 2 OR abnormal exercise test with severe SOB, abnormal blood pressure response, or arrhythmia] AND Coronary artery disease defined as: (at least 1 coronary artery lesion of >70% visual angiographic diameter stenosis in a vessel that is at least 2.5 mm in diameter and that is amenable to treatment with percutaneous coronary intervention (PCI)) AND Consensus by the Multidisciplinary Heart Team that the patient is suitable for elective transfemoral transcatheter aortic valve replacement (TAVR) with a balloon expandable transcatheter heart valve AND would receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were undergoing surgical aortic valve replacement. AND Succcessful TAVR with balloon-expandable transcatheter heart valve within the past 24 hr PCI already performed within 90 days or during elective transfemoral TAVR Planned revascularization of coronary artery lesion(s) Planned surgical revascularization Non-cardiovascular co-morbidity reducing life expectancy to < 5 years Any factor precluding 5-year follow-up Prior coronary artery bypass grafting surgery or surgical valve replacement Aortic annulus diameter < 16 mm or > 28 mm (3D imaging) Severe aortic regurgitation (> 3+) or mitral regurgitation (> 3+) Severe left ventricular dysfunction (LVEF < 30%) Severe calcification of aortic valvar complex (esp. left ventricular outflow tract) | 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): 65.0-999.0, Aortic Valve Stenosis Key Cohort A (Moderate, Symptomatic Aortic Stenosis) Moderate aortic stenosis (aortic valve area >1.0 cm^2 & <1.5 cm^2) New York Heart Association (NYHA) functional classification ≥II, with symptoms attributable to aortic stenosis Left Ventricular Ejection Fraction (LVEF) >20% by 2-D echo Key Cohort A (Moderate, Symptomatic Aortic Stenosis) Age <65 years Class I indication for cardiac surgery Bicuspid, unicuspid, or quadricuspid aortic valve In need of and suitable for coronary revascularization Key Cohort B (Severe, Asymptomatic Aortic Stenosis) Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec Subject denies symptoms attributable to aortic stenosis, including but not limited to Dyspnea on rest or exertion Angina Syncope in the absence of another identifiable cause | 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 At least 18 years of age Documented bicuspid aortic valve identified via clinical imaging (e.g., CT, MRI, or echocardiogram) with minimal calcification at the time of enrollment Participant must sign the informed consent form Pregnancy (determined by point of care urine pregnancy test) Renal failure (estimated Glomerular Filtration Rate (eGFR) < 30), precluding them from receiving intravenous contrast) Documentation of previous intravenous contrast allergy (unless they are having a CT with steroid preparation as part of routine clinical care) Previous aortic valve replacement | 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): 18.0-50.0, Postoperative Pain Edema Swelling Lips & Face To be treated patients will not have to show signs of gingival inflammation. Patients undergoing periodontal surgery should have completed non-surgical causal therapy and presented FMBS and FMPS values of 20% All subjects with positive anamensis for relevant systemic pathologies (renal, cardiovascular, hepatic, infectious, neoplastic and diabetological), treatment with anti-inflammatory and/or antibiotics in the two weeks preceding the start of the trial will be excluded, history of allergy to one or more components of the medication to be tested, pregnant 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, Severe Symptomatic Aortic Stenosis Adults older than 18 years. For female of childbearing age, active contraceptive method is recommended patients with severe symptomatic aortic stenosis secondary to degenerative disease confirmed by transthoracic echocardiography (mean gradient >40 mmHg and/or valve area <1 cm2) and with significant coronary artery disease (epicardial coronary stenosis angiography > or = to 50%) Severe CAD with tritroncular lesions or severe stenosis (>90 %) of left main artery or proximal left anterior descending artery Lack of viability in myocardial territory of interest History of bypass coronary surgery or heart transplantation Severe left ventricular systolic dysfunction, characterized by an ejection fraction < 35 % Severe renal impairment (Creatinine clearance <30 ml/min/1.73 m2) Absolute contraindication to intravenous adenosin Pregnant or nursing women Patients under guardianship, curatorship, or protection of justice | 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 Subjects suffering from severe symptomatic aortic valve stenosis according to ESC 2017 definition, including subjects with a bicuspid valve Patient is not eligible for TAVR/SAVR according to local Heart Team Age ≥18 years Subjects who are willing to provide a written informed consent prior to participating in the study Subjects who can comply with the study follow up or other study requirements Patient is eligible for the Valvosoft procedure according to CRC Subjects with any electrical device implanted Subjects with unstable arrhythmia not controlled by medical treatment Subjects with implanted mechanical valve in any position or bio prosthetic valve in aortic position Subjects with complex congenital heart disease Chest deformity Cardiogenic shock History of heart transplant Subjects requiring other cardiac surgery procedures (bypass graft surgery, mitral valve procedure, tricuspid valve procedure) within one month after treatment Thrombus in heart Acute myocardial infarction (MI), stroke or transient ischemic attack (TIA) within one month prior to enrolment* | 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 Stenosis Symptomatic Aortic Valve Stenosis severe symptomatic aortic valve stenosis high risk or patients deemed amenable for TAVI by a multidisciplinary team signed informed consent to participate in the study inadequate annulus size (<18 mm, >29 mm) left ventricle thrombus active endocarditis high risk of coronary ostium obstruction plaques with mobile thrombi in the ascending aorta, or arch hemodynamic instability estimated life expectancy <1 year comorbidity suggesting lack of improvement of quality of life other situations adjudicated by the local HeartTeam | 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, Acute Aortic Syndrome Aortopathy (1) Patients with aortic dissection/ulceration/intermural hematoma who underwent aortic arch replacement or endoluminal isolation or hybrid therapy (2) Paitents without clinically significant hyperlipidemia but with cardiovascular disease risk factors (such as male ≥45 years old, female ≥55 years old, hypertension, diabetes, chronic kidney disease, obesity, low HDL cholesterol, smoking, alcohol consumption, family history of early onset ischemic cardiovascular disease) and no previous use of statins (3) Patients are between 18 and 85 years old, male or female (4) Agree to participate in the study and sign the informed consent (1) Patients with allergy to statins (2) patients with active liver disease (3) patients with myopathy (4) Lactating women and pregnant women (5) Patients with mental diseases, drug and alcohol dependence (6) Refuse to participate in the study or sign the 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): 40.0-999.0, Cardiovascular Diseases Hypertension Must be able to understand and provide informed consent Adults >= 40 years of age Must have a history of occupational exposure to secondhand tobacco smoke for at least 5 years such as flight attendants who worked for airlines before the smoking ban on aircrafts went into effect or casino workers who worked at casinos with no smoke-free policies Must have never smoked or have a remote history of light smoking defined as follows Lifetime smoking history equivalent to < 1 pack-year and No smoking history for >= 20 years at the time of enrollment Inability or unwillingness of a participant to give written informed consent or comply with study protocol Subject is pregnant, breast-feeding, or plans to become pregnant Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) Known intolerance to ACE inhibitor or ARB History of angioedema Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy) Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting Known unilateral or bilateral renal artery stenosis higher than 70% Renal insufficiency (Creatinine Clearance <30 mL/min by Cockcroft-Gault calculation) Current regular use of NSAIDs defined as daily use on 5 or more days of the week for more than one month | 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 Aortic Valve Stenosis Age > 18 years Moderate to severe degenerative aortic valve stenosis as defined by transthoracic echocardiography according to the 2017 ESC/EACTS guidelines for the management of valvular heart disease Auto-inflammatory or auto-immune diseases Use of anti-inflammatory drugs Vaccination less than one month before Bone marrow transplantation in medical history Active hematological 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): 60.0-999.0, Aortic Stenosis Aortic Stenosis With Bicuspid Valve Age ≥ 65 years Age <65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment Severe, bicuspid aortic stenosis Mean gradient ≥40 mmHg Maximal aortic valve velocity ≥4.0 m/sec Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2) NYHA classification ≥ II Type 0, type 1 (Sievers classification) by MDCT Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm Transfemoral TAVR Any contra-indication for Self-expanding bioprosthetic aortic valve deployment Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt< 50,000 cell/mL) Active sepsis, including active bacterial endocarditis with or without treatment Evidence of an acute myocardial infarction ≤ 1 month (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)] Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure Estimated life expectancy < 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease Any Emergent surgery required before TAVR procedure A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT/HITTS) and bivalirudin, clopidogrel,Nitinol (titanium or nickel),contrast media Gastrointestinal (GI) bleeding that would preclude anticoagulation Subject refuses a blood transfusion | 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, Heart Failure Mitral Regurgitation All patients must meet clinical and anatomic for commercial placement of MitraClip for functional MR, as specified by the MitraClip Instructions for Use (IFU). a. Clinical for MitraClip: i. Symptomatic secondary MR (moderate-severe [3+ or 4+] or greater) due to ischemic or non-ischemic cardiomyopathy ii. NYHA functional class III, or ambulatory IV iii. Maximization of GDMT as directed by the "Heart Team", including an interventional cardiologist (implanting physician), heart failure cardiologist, and cardiothoracic surgeon. This includes adequate treatment for systolic HF (LV dysfunction), rhythm disorders, and coronary disease, if applicable 1. An inhibitor of the reninangiotensin system (RAS inhibitor), including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and a beta-blocker (BB) 2. Other medications recommended for selected populations, e.g., mineralocorticoid receptor antagonist (MRA) or nitrates/hydralazine should be used in appropriate patients, according to the published guidelines. 3. Patient has been on stable HF medications as determined by the investigator, for at least 1 month, with the exception of diuretic therapy. Stable is defined as no more than a 100% increase or 50% decrease in dose within these periods. 4. Drug intolerance, contraindications, or lack of indications must be attested to by the investigator. 5. Receiving Class I recommended cardiac rhythm management device therapy. 1. If indicated by class I guidelines, cardiac resynchronization therapy (CRT), implanted cardioverter-defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to device implantation 2. These may be waived if a patient is clinically contraindicated for these therapies or refuses them and must be attested to by the investigator. iv. At least one hospitalization for heart failure in last year OR corrected BNP ≥ 300 pg/mL or corrected NTproBNP ≥ 1500 pg/mL v. Heart team has determined that mitral valve (MV) surgery will not be offered as a treatment option b. Anatomic for MitraClip: i. LVEF ≥ 20% and ≤ 50% ii. LV end-systolic dimension ≤ 70 mm iii. MV orifice area > 4.0 cm2 by TEE iv. Minimal calcification in the grasping area v. No leaflet cleft in the grasping area vi. In patients with a degenerative component to MR, the following additional must be met: 1. Flail width <15 mm 2. Flail gap <10 mm vii. The primary regurgitant jet is non-commissural, and in the opinion of the implanting investigator can be successfully be treated by the MitraClip (if a secondary jet exists, it must be considered clinically insignificant) viii. Transseptal catheterization and femoral vein access is feasible per investigator 2. Provide written informed consent for study participation and be willing and able to comply with the required tests, treatment instructions and follow-up visits Preliminary (PEC) to assessed by the Preliminary Screen at the baseline visit: 1. Severe pulmonary hypertension, defined as RV systolic pressure or PA systolic pressure > 70 mmHg, or PVR > 4 Woods units, measured by any modality (TTE, TEE, cardiac MRI, or pulmonary artery catheterization [if data available]). 2. Moderate or severe RV dysfunction defined as TAPSE <12mm or RVFAC ≤25% as assessed on Baseline TTE, or qualitative assessment of severe RV dysfunction on TTE, TEE, or cardiac MRI. 3. Untreated severe (3+ to 4+) tricuspid or pulmonary regurgitation. 4. Untreated clinically significant coronary disease requiring revascularization 5. Coronary artery bypass grafting, percutaneous coronary intervention, transcatheter aortic valve implantation, or CRT-D implantation within 30 days 6. Aortic or tricuspid valve requiring surgery or transcatheter intervention 7. COPD requiring continuous home oxygen therapy or chronic outpatient steroid use 8. Cerebrovascular accident within prior 30 days 9. Known severe symptomatic carotid stenosis 10. Carotid surgery or stenting within prior 30 days 11. ACC/AHA Stage D heart failure 12. Presence of any of the following: 1. Hypertrophy cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology 2. Infiltrative cardiomyopathy (e.g. amyloidosis, hemochromatosis, sarcoidosis) 13. Leaflet anatomy which may preclude MitraClip implantation 14. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 15. Need for surgery within 12 months 16. Life expectancy < 1 year due to non-cardiac conditions 17. Status 1 for cardiac transplant or history of cardiac transplant 18. Modified Rankin score ≥ 4 for disability 19. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure 20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation 21. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated) 22. Active infection requiring antibiotic therapy 23. TEE is contraindicated or high risk 24. Pregnant or planning pregnancy within 12 months 25. Known hypersensitivity or contraindication to procedural medications that cannot be adequately treated 26. Known allergy to nickel. 27. Patient is otherwise not appropriate for the study as determined by the investigator or the Committee, for which the reasons must be documented. 28. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. Final (FEC) Assessed by the Final Screening, performed at time of cardiac catheterization prior to device placement (Study Intervention Visit) 29. Presence of severe pulmonary hypertension assessed by invasive hemodynamic measurement with pulmonary artery catheterization prior to MitraClip placement, defined as PA systolic pressure > 70 mmHg or PVR > 4 Woods units. 30. Anatomical anomaly on TEE that precludes implantation of the study device across the interatrial communication created by the MitraClip procedure, including: 1. A posterior rim between the septum secundum and aorta (i.e. aortic rim) of < 5 mm. 2. Atrial septal aneurysm defined as ≥ 10 mm of phasic septal excursion into either atrium or a sum total excursion of ≥ 15 mm during the cardiorespiratory cycle, with a base of ≥ 15 mm. 31. Moderate or worse MR ≥2+ at the end of MitraClip treatment (i.e. MR must be <2+ by TTE, TEE, invasive hemodynamics, or left ventriculography) 32. Key hemodynamic exclusions after MitraClip treatment: 1. Mean LAP ≤ 20 mmHg following final result from MitraClip placement (i.e. mean LAP must be elevated > 20 mmHg after completion of MitraClip). 2. Difference between mean LAP and mean RAP < 5mmHg after MitraClip placement (i.e. difference between LAP RAP must be ≥ 5 mmHg). 3. If the patient meets these hemodynamic and mean arterial pressure (MAP) is < 90 mmHg, the MAP may be increased to ≥ 90 mmHg and repeat pressure measurements obtained in order to evaluate eligibility. i. IV fluids and medications may be given to support MAP to a goal ≥ 90 mmHg if necessary. 33. Patient is otherwise not appropriate for study as determined by the 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): 18.0-999.0, Atrial Fibrillation Heart Failure Patients with the previous diagnosis of HF with both preserved and depressed LVEF. Patients with preserved or intermediate LVEF will be defined according to current guidelines. 1. Patients with signs and symptoms of HFor b) LVEF between 40 and 49 for "mid range" and greater than or equal to 50 for those with LVEF preserved, high natriuretic peptides (BNP> 35 pg / ml and / or NT-proBNP> 125 pg / mL)and at least one of these two Relevant structural disease (left ventricular hypertrophy or dilatation left earphone). Diastolic dysfunction Previous history of atrial fibrillation CHA2DS2VASc < 2 Patients requiring ventricular pacing > 40 patients Patients under cardiac resynchronization therapy pacemaker/devices Patients with severe valvulopathy Patients with reverseble | 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, Thoracic Aortic Aneurysm Bicuspid Cardiac Valve Age >18 years First-time surgery Bicuspid aortic valve confirmed Thoracic aortic aneurysm involving aortic root or ascending aorta No available pre-operative cross-sectional imaging Re-do surgery | 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, ST Elevation Myocardial Infarction Remodeling, Left Ventricle STEMI with time from symptom onset of <48 hours duration I. Clinical STEMI patients receiving fibrinolytic therapy. 2. Cardiogenic shock, clinical, hemodynamic, or electrical instability persisting after primary PCI. 3. History of prior ST elevation myocardial infarction. 4. Unsuccessful angiographic reperfusion (Thrombolysis In Myocardial Infarction [TIMI] flow grade <2). II. Contraindications to CMR: 1. Cerebral aneurysm clips 2. Cardiovascular implanted electronic devices 3. Electronic implant or device, eg, insulin pump or other infusion pump 4. Cochlear or otologic implant 5. Shunt (spinal or intraventricular) 6. Tissue expander (eg, breast) 7. Metallic foreign body, especially ocular 8. Penile prosthesis. 9. Patients with stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate <30 mL/min/1.73 m2) 10. Known claustrophobia 11. Known/possible pregnancy | 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): 18.0-80.0, Aortic Valve Regurgitation Aortic Root Aneurysm Patients with Tricuspid Aortic Valve (TAV) operated electively for aortic valve regurgitation and or ascending aorta dilatation Acute aortic dissection Diffuse aortic valve calcification AV endocarditis Bicuspid, unicuspid or quadricuspid aortic valves Patients under the age of 18 years Patients above the age of 80 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): 0.0-999.0, Aortic Valve Disease Subject with AV disease Documented symptomatic moderate or greater aortic stenosis small aortic annulus patients A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic valve (especially in paediatric population), and aortic valve cusp perforation from endocarditis Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly Patients with previous aortic valve surgery missing informed consent Participation in another clinical research | 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 or any alternative access TAVI, based on MSCT assessment and local expertise and preference. 5. Estimated life expectancy>1 year Age <18 years 2. Estimated life expectancy<1 year 3. Pure aortic regurgitation. 4. LVEF<20% 5. No baseline MSCT evaluation | 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 Aortic Valve Stenosis Echocardiographic transaortic mean gradient ≥ 20mmHg OR VARC-3 for ≥ moderate hemodynamic valve deterioration post TAVR on any TTE > 1 month post-TAVR Consensus by the Heart Team that the patient is suitable for Standardized Invasive Hemodynamics (SIH) CT demonstrating leaflet thrombosis or hypoattenuated leaflet thickening (HALT) | 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, Ankle Arthritis Arthritis Foot Meets indications for TTC arthrodesis and receives the DynaNail implant Able to understand the requirements of the study Willing to comply with the study protocol Sign an Informed consent years of age or older Investigator determines that the subject is unlikely to comply with the requirements of the study Non-English speaker Blind Illiterate Prisoner | 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 Valve Stenosis Age ≥ 70 years ; 2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm2, or AVA <0.5cm2 /m2); 3. NYHA ≥ II; 4. Life expectancy> 12 months; 5. Patients who are anatomically suitable for transcatheter aortic valve implantation; 6. After evaluation by two or more cardiovascular surgeons, patients who are unsuitable for surgery; or patients who refuse surgery after sufficient communication by the surgeons and are at high risk of routine surgery; 7. Patients who can understand the purpose of the trial, voluntarily participate in and signed informed consent form, and are willing to accept relevant examinations and clinical follow-ups Acute myocardial infarction occurred within 1 month before this treatment; 2. Congenital single leaf aortic valve; 3. Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days; 4. The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation (>3+); 5. Blood system diseases or abnormalities, including leukopenia (WBC<3×109/L), acute anemia (HB <90g/L), thrombocytopenia (PLT<50×109/L), bleeding constitution and coagulopathy ； 6. Untreated severe coronary artery stenosis that requires revascularization; 7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation; 8. Patients who need emergency surgery for any reason; 9. Hypertrophic cardiomyopathy with obstruction; 10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%; 11. The echocardiogram indicates the presence of a heart mass, thrombus or vegetation; 12. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; 13. Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy; 14. The diameter of the aortic valve annulus <16mm or >28mm; 15. In any case, patients who refuse surgical treatment in emergency situations; 16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack; 17. Renal insufficiency is decompensated (creatinine>177umol/L), and/or end-stage renal disease requires long-term dialysis; 18. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic aorta; 19. The iliac-femoral artery is severely obstructed with calcification, severely tortuous or unable to place the 1418F catheter sheath kit; 20. Active infective endocarditis or other active infections; 21. Aortic valve leaflets calcified plaque close to the coronary ostium; 22. Severe disability Alzheimer's disease and unable to take care of oneself in life; 23. Those who have participated in clinical trials of other drugs or medical devices before entering the group and have not yet reached the time limit of the primary research endpoint; 24. The researcher judged that the patient had poor compliance and could not complete the study as required | 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): 0.0-79.0, Aortic Stenosis Aortic Valve Stenosis Will undergo TAVI with the Edwards 3 Ultra System 2. Less than 80 years of age at time of the procedure 3. Low surgical risk 4. Meets clinical and procedural requirements for early discharge 5. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship 2. Considered to be part of a vulnerable population 3. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 4. Cannot tolerate an anticoagulation/antiplatelet regimen 5. Active bacterial endocarditis 6. Participating in a drug or device study that has not reached its primary endpoint | 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): 65.0-999.0, Symptomatic Aortic Stenosis Male and Female 2. Age ≥ 65 years at time of consent 3. Women of non-childbearing potential 4. Severe degenerative calcific native aortic valve stenosis with the following assessed either by resting or dobutamine stress TTE: 1. Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and 2. Jet velocity > 4.0 m/s or mean gradient > 40 mmHg 5. Symptomatic aortic stenosis (AS), defined as a history of at least one of the following: 1. Dyspnea that qualifies at NYHA class II or greater 2. Angina pectoris 3. Cardiac syncope 6. Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following: 1. EuroSCORE II ≥ 4% 2. Agreement by the Heart Team that subject is at high operative risk of serious morbidity or mortality with surgical valve replacement 7. The local Heart Team, including at least 1 cardiothoracic surgeon and 1 interventional cardiologist, deems the patient to be eligible for transfemoral TAVI. 8. Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) performed within 90 days prior to planned implantation 9. Adequate iliofemoral access with minimum average vessel diameter of ≥ 6.0mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath 10. The distance from coronary ostia to aortic anulus > 12 mm 11. Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent. 12. The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits Cardiovascular System: 1. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves. 2. Evidence of an acute myocardial infarction (MI) ≤ 30 days before the IMD implantation (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). 3. Patient has had a cerebrovascular stroke or TIA within the past 90 days before IMD implantation. 4. Patient has a hypertrophic obstructive cardiomyopathy. 5. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to the planned IMD implantation (except for pacemaker implantation which is allowed). 6. Untreated clinically significant coronary artery disease requiring revascularization at the screening visit. 7. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography within 90 days prior. 8. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support 9. Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block >I) at screening and at time of valve implantation. 10. Patient has severe peripheral vascular disease: 1. including aortic aneurysm defined as maximal luminal diameter > 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [> 5 mm], protruding or ulcerated atheroma in the aortic arch) or 2. symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days before IMD implantation. 11. Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer [severe calcification, tortuosity (> two 90-degree bends), diameter < 6mm, or subject has had an aorto-femoral bypass] 12. Patient with active bacterial endocarditis within 6 months of planned IMD 13. Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation. 14. Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion). 15. Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis. 16. Patient has a need for emergency surgery for any reason at time of screening and valve implantation. General: 17. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy) 18. Patient with renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level > 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening 19. Patient with significant pulmonary disease (FEV1 < 30%) or currently on home oxygen 20. Severe pulmonary hypertension (e.g., PA systolic pressure / systemic pressure >1 or mean pulmonary pressure > 55 mmHg assessed by echocardiography) 21. Patients with evidence of an active systemic infection or sepsis 22. Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin. 23. Patient has a hemoglobin < 9 g/dL, platelet count < 50,000 cells/mm3 or > 700.000 cells/mm3, or white blood cell count < 1.000 cells/mm3, history of bleeding diathesis or coagulopathy 24. Patient has peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months. 25. Patient refuses blood transfusions. 26. Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment. 27. Patient is pregnant or breast feeding. 28. 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). 29. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams 30. Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies) | 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, Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class IV Heart Failure With Preserved Ejection Fraction Heart Failure With Mid Range Ejection Fraction Hypertrophy, Left Ventricular Cardiac Amyloidosis Age ≥ 60 years Symptomatic heart failure (NYHA II-IV) with LVEF ≥40% Increased LV wall thickness (≥12mm end-diastolic) NT-proBNP ≥1000pg/mL Elevated hs-troponin T ≥14ng/L Contraindications for CMR Acute myocarditis Acute myocardial infarction <1 month Severe aortic stenosis and RAISE score < 2 points | 1 |
A 32 yo woman who presents following a severe 'exploding' headache. She and her husband report that yesterday she was in the kitchen and stood up and hit her head on the corner of a cabinet. The next morning she developed a sudden 'exploding' headache. She came to the hospital where head CT showed a significant amount of blood in her right ventricle. NSGY evaluated her for spontaneous intraventricular hemorrhage with a concern for an underlying vascular malformation. Cerebral angiogram was done which showed abnormal vasculature with a draining vein from L temporal lobe penetrating deep white matter consistent with AVM. The patient did continue to have a headaches but they were improving with pain medication. The patient refused PT evaluation but was ambulating independently without difficulty. She was discharged to home with her husband on [**2155-12-6**]. | eligible ages (years): 0.0-999.0, HIV Infections Pregnancy A patient may be eligible for this study if she Is an HIV-positive woman Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available Had a baby on or after January 1, 1998 | 0 |