j-valve tf early feasibility study

Conditions: Aortic Valve Disease; Aortic Valve Insufficiency; Aortic Regurgitation

Summary: the main objective of this study is to assess the preliminary safety and effectiveness of the j-valve tf system in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

the efs is a prospective, single arm, multi-center, interventional study that will enroll up to 25 subjects in up to 15 centers in the united states and/or canada and report the primary endpoint of all-cause death or disabling stroke at 30 days.

Eligibility criteria:
inclusion criteria: * patient has symptomatic (nyha fc ≥ iis) severe (≥3+) native ar (per 2020 acc/aha guideline for management of patients with valvular heart disease) diagnosed by echocardiography. patients will be assessed according to the current american society of echocardiography guidelines for non-invasive evaluation of native valve regurgitation. transesophageal echocardiography (tee) or cardiac mri (cmr) will be used in case of indeterminant ar; * patient is judged by a multi-disciplinary heart team to be at high risk for surgery, based on the acc/aha guidelines for management of patients with valvular heart disease: sts-prom score ≥8%, or if \<8%, significant co-morbidities that are not captured by the sts-prom score (e.g., ≥2 frailty indices, 1 to 2 major organ system compromise, the presence of certain procedure-specific factors that affect surgical mortality), based on the consensus of a multi-disciplinary heart team; * patient has suitable anatomy for j-valve implantation (see anatomic exclusions below); * patient or the patient's legal representative has provided written informed consent; * patient or patient's legal representative agrees to comply with all required post-procedure follow-up visits. exclusion criteria: * patients that are at prohibitive surgical risk (predicted risk for mortality or major morbidity at 30 days \>50% with savr); * mixed aortic valve disease, defined as coexistence of \> moderate aortic valve stenosis with severe ar; * known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, nitinol (nickel, titanium, aluminum) or sensitivity to contrast media, which cannot be adequately premedicated; * blood dyscrasias as defined: leukopenia (wbc \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy; * active infection, including infective endocarditis; * liver failure (child-c); * reduced left ventricular function with left ventricular ejection fraction (lvef) \<25% as measured by resting echocardiogram; * uncontrolled atrial fibrillation (e.g., resting heart rate \>120 bpm); * pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements; * renal insufficiency (egfr \<25) and/or end stage renal disease requiring chronic dialysis; * pulmonary hypertension (systolic pressure ≥2/3 of systemic); * severe chronic obstructive pulmonary disease (copd) = requiring steroids or requiring continuous home o2 * severe mitral or severe tricuspid regurgitation or stenosis; * symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of treatment; * cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; * recent (within 6 months of treatment) cerebrovascular accident (cva) or transient ischemic attack (tia); * active gastrointestinal (gi) bleeding that would preclude anticoagulation; * untreated multivessel coronary artery disease with a syntax score \>22 and/or unprotected left main coronary artery; * evidence of acute myocardial infarction within 1 month of intended procedure; * pci within 30 days of intended procedure; * estimated life expectancy of less than 24 months due to associated (excluding cardiac) co-morbid conditions; * left ventricular assist device (lvad) dependent; * participating in another study that may influence the outcome of this study; * need for emergency surgery for any reason; * previous aortic bioprosthesis or mechanical implant. anatomic exclusion criteria: * ascending aortic diameter \>5 cm; * aortic annulus perimeter \ 104 mm; * access vessel minimum diameter \<5.5 mm; * lvedd \>75 mm; * bicuspid aortic valve disease; * congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk. * abdominal aortic aneurysm ≥ 4.0 cm; * aorto-iliac disease requiring intervention to facilitate delivery of access sheath; * excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, descending aorta, ascending aorta, aortic arch, and aortic angle \>80⁰. in most cases, this exclusion will be identified and assigned following review by the multi-disciplinary screening committee.

Keywords: j-valve tf system transcatheter aortic valve replacement transcatheter aortic valve implantation transcatheter heart valve transfemoral tavr tavi thv vhd valvular heart disease valve disease