JOURNEY
J-Valve Transfemoral Pivotal Study
AI Description
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 join
- adult, older adult
- Participants
- 194
- Expected completion
- 2032-02
- Funded by
- industry
Conditions studied
Aortic Valve Disease Mixed, Aortic Valve Regurgitation
What is being tested
- DEVICE: J-Valve Transfemoral (TF) System
What it measures
- All-cause mortality at 1 year, 1-year post-procedure
- 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, 30-days post-procedure
Working with
Cardiovascular Research Foundation, New York, Minneapolis Heart Institute Foundation
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Ascension Saint Thomas Hospital
Nashville, TN
Ascension Via Christi (Wichita)
Wichita, KS
Atrium Health Carolinas Medical Center
Charlotte, NC
Barnes-Jewish Hospital
Saint Louis, MO
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Brigham and Women's Hospital
Boston, MA
California Pacific Medical Center (Van Ness Campus)
San Francisco, CA
Cedars-Sinai Medical Center
Los Angeles, CA
CentraCare – St. Cloud Hospital
Saint Cloud, MN
Emory University Hospital Midtown
Atlanta, GA
HCA Houston Healthcare Medical Center
Houston, TX
Henry Ford Health (Detroit)
Detroit, MI
HonorHealth Scottsdale Shea Medical Center
Scottsdale, AZ
Houston Methodist Hospital
Houston, TX
Kaleida Health
Buffalo, NY
Massachusetts General Hospital
Boston, MA
MedStar Washington Hospital Center
Washington, DC
Montefiore Einstein Hospital (Moses Campus)
Bronx, NY
Naples Comprehensive Health (NCH)
Naples, FL
Northwestern Memorial Hospital
Chicago, IL
OHSU Hospital
Portland, OR
Piedmont Atlanta Hospital
Atlanta, GA
Scripps Memorial Hospital La Jolla
La Jolla, CA
St. Francis Hospital & Heart Center
Roslyn, NY
Stanford Health Care
Stanford, CA
Swedish Cherry Hill Campus
Seattle, WA
The Christ Hospital
Cincinnati, OH
UCHealth Medical Center of the Rockies
Loveland, CO
UCSF Health
San Francisco, CA
Vanderbilt University Medical Center
Nashville, TN
Registry entry updated 2026-05-04
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.