J-Valve TF Early Feasibility Study

Running, not enrolling · Not applicable

Conditions studied: Aortic Valve Disease, Aortic Valve Insufficiency, Aortic Regurgitation

In brief

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.

Key facts

Study ID

NCT06034028

Run by

JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

People needed

25

Starts

2023-10-16

Expected to finish

2029-08-25

Last updated by the study team

2025-07-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• HonorHealth — Scottsdale, Arizona, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• University at Buffalo — Buffalo, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Swedish Medical Center Cherry Hill — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.