Condition: Aortic Valve Regurgitation · Aortic Valve Disease Mixed · Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
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.
This description comes directly from the study's public registry record.
Sheri L Halverson, MPH · 1-800-424-3278 · sheri_halverson@edwards.com
Always discuss trial participation with your own doctor first.
| HonorHealth Research & Innovation Institute | Scottsdale, Arizona, United States | Recruiting |
| Scripps Memorial Hospital La Jolla | La Jolla, California, United States | Recruiting |
| Cedars Sinai | Los Angeles, California, United States | Recruiting |
| Stanford University Medical Center | Palo Alto, California, United States | Recruiting |
| Bay Area Structural Heart at Sutter Health | San Francisco, California, United States | Recruiting |
| University of California San Francisco | San Francisco, California, United States | Recruiting |
| UC Health Northern Colorado (Medical Center of the Rockies) | Loveland, Colorado, United States | Recruiting |
| Washington Hospital Center DC | Washington D.C., District of Columbia, United States | Recruiting |
| NCH Rooney Heart Institute | Naples, Florida, United States | Recruiting |
| Emory University Atlanta | Atlanta, Georgia, United States | Recruiting |
| Piedmont | Atlanta, Georgia, United States | Recruiting |
| Northwestern University Chicago | Chicago, Illinois, United States | Recruiting |
+ 28 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06455787