The JenaValve ALIGN-AR LVAD Registry (NCT06594705)
Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients With Left Ventricular Assist Devices (LVAD)
🩺 Plain-English Summary (8th-Grade Level)
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Center — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- Cedars-Sinai Medical Center — Los Angeles, California
- Sutter Health — San Francisco, California
- Medstar Washington Hospital Center — Washington D.C., District of Columbia
- Piedmont — Atlanta, Georgia
- Advocate Christ Medical Center — Oak Lawn, Illinois
- University of Michigan — Ann Arbor, Michigan
- Henry Ford Hospital — Detroit, Michigan
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota
- Washington University, St. Louis — St Louis, Missouri
- Columbia University Medical Center/New York-Presbyterian Hospital — New York, New York
- Houston Methodist Research Center — Houston, Texas
- Baylor — Plano, Texas
- Intermountain — Murray, Utah
- Sentara Norfolk General Hospital — Norfolk, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Aortic Regurgitation
- The JenaValve ALIGN-AR Pivotal Trial — Tucson, Arizona
- THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study — Los Angeles, California
- Novel Characterization of Sex Specific Biologic Signatures in Valvular Heart Disease — Cleveland, Ohio
- ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ — Burlingame, California
Explore by condition: All Aortic Regurgitation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.