Trial Summary
The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).
A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.
Lead Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Participants: ALL
Start Date: 2024-10-17
Primary Completion: 2028-02
Min Age: 18 Years
Eligibility Criteria
Inclusion Criteria: 1. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher 2. Severe AR, defined as follows, as assessed by Imaging Core Laboratory: A. Severe AR by Transthoracic Echocardiography (TTE) (grade 3 or 4) B. OR, if indeterminate AR, by TTE, ANY ONE of the following: i. Cardiac magnetic resonance imaging (CMR)-derived aortic regurgitant fraction (RF) ≥43% ii. CMR-derived RF ≥33% + left ventricular dilation (left ventricular end diastolic volume index [LVEDVi]) >105 mL/m^2 for men or LVEDVi >96 mL/m^2 for women) iii. CMR-derived RF ≥33% + LV ejection fraction (LVEF) ≤55% or left ventricular end systolic volume index (LVESVi) ≥43mL/m^2; iv. Severe AR by Transesophageal Echocardiography (TEE) (grade 3 or 4) 3. High risk for surgery as judged by a multi-disciplinary heart team 4. Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below) 5. Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site. Exclusion Criteria: 1. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant 2. Aortic valve stenosis > moderate* 3. Severe mitral valve or tricuspid valve regurgitation* 4. Severe mitral valve or tricuspid valve stenosis* 5. Active…
Data sourced from ClinicalTrials.gov. Trial details may change — always check the primary source before clinical decisions.