J-Valve TF Early Feasibility Study
Purpose
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.
Conditions
- Aortic Valve Disease
- Aortic Valve Insufficiency
- Aortic Regurgitation
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental J-Valve TF System |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Study Contact
Detailed 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.