System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Active not recruiting

NCT06455787 on ClinicalTrials.gov

J-Valve Transfemoral Pivotal Study

Official title: J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

  • Sponsor: Edwards Lifesciences (Group)
  • Collaborators: Minneapolis Heart Institute Foundation, Cardiovascular Research Foundation, New York
  • Enrollment: 194 (Estimated)
  • Study start: 2024-10-17 (Actual)
  • Primary completion: 2028-02-01 (Estimated)
  • Study completion: 2032-02-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: The investigation is a prospective, single arm, multi-center, interventional pivotal study.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Aortic Valve Regurgitation
  • Aortic Valve Disease Mixed

Intervention / Treatment

  • Device: J-Valve Transfemoral (TF) System

Primary Outcome 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) (30-days post-procedure)
    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

Countries

Canada, France, Japan, United Kingdom, United States

Locations and Investigators

  • Banner University Medical Center - Phoenix, Phoenix, United States
  • HonorHealth Research & Innovation Institute, Scottsdale, United States
  • Scripps Memorial Hospital La Jolla, La Jolla, United States
  • Cedars Sinai, Los Angeles, United States
  • Stanford University Medical Center, Palo Alto, United States
  • Bay Area Structural Heart at Sutter Health, San Francisco, United States
  • University of California San Francisco, San Francisco, United States
  • UC Health Northern Colorado (Medical Center of the Rockies), Loveland, United States
  • Washington Hospital Center DC, Washington D.C., United States
  • NCH Rooney Heart Institute, Naples, United States
  • Emory University Atlanta, Atlanta, United States
  • Piedmont, Atlanta, United States
  • Northwestern University Chicago, Chicago, United States
  • Glenbrook - Endeavor Health, Glenview, United States
  • Ascension Via Christi, Wichita, United States
  • Cardiovascular Institute of the South, Houma, United States
  • Massachusetts General Hospital Boston, Boston, United States
  • Brigham and Women's Hospital, Boston, United States
  • Henry Ford Hospital Detroit, Detroit, United States
  • Minneapolis Heart Institute Foundation, Minneapolis, United States
  • CentraCare Heart and Vascular Center, Saint Cloud, United States
  • Washington University - Barnes-Jewish Hospital St. Louis, St Louis, United States
  • University at Buffalo - Kaleida Health, Buffalo, United States
  • Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, United States
  • St. Francis Hospital, Roslyn, United States
  • Montefiore Medical Center, The Bronx, United States
  • Carolinas Health System (Atrium), Charlotte, United States
  • The Christ Hospital and The Carl & Edyth Lindner Center for Research and Education, Cincinnati, United States
  • Oregon Health & Science University, Portland, United States
  • Ascension St. Thomas West Hospital, Nashville, United States
  • Vanderbilt University Medical Center, Nashville, United States
  • HCA Houston Healthcare Medical Center, Houston, United States
  • Houston Methodist Hospital, Houston, United States
  • The Heart Hospital - Baylor Plano, Plano, United States
  • Swedish Heart & Vascular Research, Seattle, United States
  • St. Paul's Hospital Vancouver, Vancouver, Canada
  • St. Michael's Hospital, Toronto, Canada
  • Clinique Pasteur Toulouse, Toulouse, France
  • Juntendo University Hospital, Tokyo, Japan
  • Keio University Hospital, Tokyo, Japan
  • National Cerebral and Cardiovascular Center, Osaka, Japan
  • Oxford - John Radcliff Hospital, Oxford, United Kingdom

Study Officials