J-Valve TF Early Feasibility Study

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 \<57 mm or \>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.