THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

Running, not enrolling · Not applicable

Conditions studied: Aortic Regurgitation

In brief

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.

Key facts

Study ID

NCT02732704

Run by

JenaValve Technology, Inc.

People needed

100

Starts

2018-04-20

Expected to finish

2027-09-29

Last updated by the study team

2022-11-18

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

• Cedars Sinai Medical Center — Los Angeles, 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
• Piedmont Healthcare — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Michigan — Ann Arbor, Michigan, United States
• New York-Presbyterian/ Columbia University Medical Center — New York, New York, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• University of Washington — Seattle, Washington, United States
• Kerckhoff-Klinik GmbH Bad Nauheim — Bad Nauheim, Germany
• Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen — Bad Oeynhausen, Germany
• Deutsches Herzzentrum Berlin — Berlin, Germany
• Universitätsklinikum Bonn — Bonn, Germany
• Herzzentrum der Universität zu Köln — Cologne, Germany
• Universitätsklinikum Frankfurt — Frankfurt, Germany
• Universitäres Herzzentrum Hamburg — Hamburg, Germany
• Leiden University Medical Center — Leiden, Netherlands
• St. Antonius Hospital — Nieuwegein, Netherlands
• Erasmus University Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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