J-Valve Transfemoral Pivotal Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJC Medical, Inc., an affiliate of Edwards Lifesciences LLC
About this trial
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.
Eligibility criteria
Qualifiers
Symptomatic according to New York Heart Association (NYHA) functional class (FC) II or higher
High risk for surgery as judged by a multi-disciplinary heart team
Suitable anatomy to accommodate the insertion, delivery, and deployment of the study devices (see anatomic exclusions below)
Written informed consent and agreement to comply with all required post-procedure follow-up visits at investigational site.
Disqualifiers
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*
Trial design
Treatments tested in this trial
- J-Valve Transfemoral (TF) System
Treatment groups
194 Participants
are divided into 1 treatment groupSponsors and collaborators
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Lead sponsor
Minneapolis Heart Institute Foundation
Collaborator
Cardiovascular Research Foundation, New York
Collaborator
Source ClinicalTrials.gov