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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
J-Valve Transfemoral (TF) System
DeviceTreatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.
Treatment groups
194 Participants
are divided into 1 treatment groupGroup A: J-Valve Transfemoral (TF) SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality at 1 year
Time frame
1-year post-procedure2
The composite rate of early-safety outcomes at 30 days as defined by the Valve Academic Research Consortium 3 (VARC-3)
Includes: * All-cause death * All stroke * VARC-3 type 2-4 bleeding * Major vascular, access-related, or cardiac structural complication * Acute kidney injury (AKI) stage 3 or 4 * New permanent pacemaker due to procedure-related conduction abnormalities * Surgery or intervention related to the device
Time frame
30-days post-procedureSecondary outcomes
1
Rate of improvement in cardiovascular-specific health status
As measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS)
Time frame
Baseline to 1-year follow-up2
Improvement in left ventricular end diastolic diameter index (LVEDDi)
To measure LV remodeling
Time frame
Baseline to 1-year follow-up3
Improvement in left ventricular end diastolic volume index (LVEDVi)
To measure LV remodeling
Time frame
Baseline to 1-year follow-up4
Improvement in effective stroke volume index (ESVi)
To measure LV remodeling
Time frame
Baseline to 1-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
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