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.

Age: All ages

Gender: All

Start Date: 10/16/2023

Primary Completion Date (Estimated): 07/17/2024

Study Completion Date (Estimated): 08/25/2029

Accepts Healthy Volunteers: No

Trial Purpose and Description

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

Age: All ages

Gender: All

Accepts Healthy Volunteers: No

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.