THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study (NCT02732704)
THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)
🩺 Plain-English Summary (8th-Grade Level)
To collect information about treatment for 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: 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 (19 Sites)
- Cedars Sinai Medical Center — Los Angeles, California
- California Pacific Medical Center Research Institute — San Francisco, California
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Piedmont Healthcare — Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia
- University of Michigan — Ann Arbor, Michigan
- New York-Presbyterian/ Columbia University Medical Center — New York, New York
- Baylor Scott & White Research Institute — Dallas, Texas
- University of Washington — Seattle, Washington
- Kerckhoff-Klinik GmbH Bad Nauheim — Bad Nauheim,
- Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen — Bad Oeynhausen,
- Deutsches Herzzentrum Berlin — Berlin,
- Universitätsklinikum Bonn — Bonn,
- Herzzentrum der Universität zu Köln — Cologne,
- Universitätsklinikum Frankfurt — Frankfurt,
- Universitäres Herzzentrum Hamburg — Hamburg,
- Leiden University Medical Center — Leiden,
- St. Antonius Hospital — Nieuwegein,
- Erasmus University Medical Center — Rotterdam,
💰 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 JenaValve ALIGN-AR LVAD Registry — 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.