J-Valve Transfemoral Pivotal Study (NCT06455787) | Clinical Trial Compass
RecruitingNot Applicable
J-Valve Transfemoral Pivotal Study
United States194 participantsStarted 2024-10-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
✓. Severe AR, defined as follows, as assessed by Imaging Core Laboratory:
✓. High risk for surgery as judged by a multi-disciplinary heart team
Exclusion criteria
✕. Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site.
✕. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
✕. Aortic valve stenosis \> moderate\*
✕. Severe mitral valve or tricuspid valve regurgitation\*
✕. Severe mitral valve or tricuspid valve stenosis\*
✕. Active infection, including infective endocarditis
✕. Cardiac imaging evidence of cardiac mass, thrombus or vegetation
What they're measuring
1
All-cause mortality at 1 year
Timeframe: 1-year post-procedure
2
The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3)
Timeframe: 30-days post-procedure
Trial details
NCT IDNCT06455787
SponsorJC Medical, Inc., an affiliate of Edwards Lifesciences LLC