The JenaValve ALIGN-AR Pivotal Trial (NCT04415047)
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
🩺 Plain-English Summary (8th-Grade Level)
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Who can join: Review the eligibility criteria below.
Location: TMC HealthCare & PIMA Heart — Tucson, Arizona
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 (30 Sites)
Showing the first 25 of 30 sites.
- TMC HealthCare & PIMA Heart — Tucson, Arizona
- Cedars Sinai Medical Center — Los Angeles, California
- Scripps Hospital — San Diego, California
- California Pacific Medical Center Research Institute — San Francisco, California
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Morton Plant/ BayCare Health — Clearwater, Florida
- Piedmont Healthcare — Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia
- Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health — Oak Lawn, Illinois
- University of Maryland Medical Center — Baltimore, Maryland
- University of Michigan — Ann Arbor, Michigan
- Henry Ford Health System — Detroit, Michigan
- Minneapolis Heart Institute/ Abbott Northwestern — Minneapolis, Minnesota
- Barnes-Jewish Hospital / Washington University — St Louis, Missouri
- Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital — Piscataway, New Jersey
- New York-Presbyterian/ Columbia University Medical Center — New York, New York
- The Christ Hospital — Cincinnati, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio
- Ohio Health Research Institute — Columbus, Ohio
- Oregon Health & Science University — Portland, Oregon
- Allegheny-Singer Health Network — Pittsburgh, Pennsylvania
- Lankenau — Wynnewood, Pennsylvania
- Medical University of South Carolina — Charleston, South Carolina
- Methodist Le Bonheur Healthcare — Memphis, Tennessee
- Baylor Scott & White Research Institute — Dallas, Texas
💰 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 LVAD Registry — Los Angeles, California
- 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.