The JenaValve ALIGN-AR Pivotal Trial

Running, not enrolling · Not applicable

Conditions studied: Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease

In brief

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.

Key facts

Study ID

NCT04415047

Run by

JenaValve Technology, Inc.

People needed

180

Starts

2020-05-22

Expected to finish

2028-08-01

Last updated by the study team

2022-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with severe aortic regurgitation (AR).
• Patient at high risk for open surgical valve replacement
• Patient symptomatic according to NYHA functional class II or higher
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

You may not qualify if…

• Congenital uni or bicuspid aortic valve morphology
• Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• Endocarditis or other active infection
• Need for urgent or emergent TAVR procedure for any reason
• Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
• Severe mitral regurgitation

Where it is running

• TMC HealthCare & PIMA Heart — Tucson, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Scripps Hospital — San Diego, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Morton Plant/ BayCare Health — Clearwater, Florida, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health — Oak Lawn, Illinois, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Minneapolis Heart Institute/ Abbott Northwestern — Minneapolis, Minnesota, United States
• Barnes-Jewish Hospital / Washington University — St Louis, Missouri, United States
• Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital — Piscataway, New Jersey, United States
• New York-Presbyterian/ Columbia University Medical Center — New York, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio Health Research Institute — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Allegheny-Singer Health Network — Pittsburgh, Pennsylvania, United States
• Lankenau — Wynnewood, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Methodist Le Bonheur Healthcare — Memphis, Tennessee, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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