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THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
Sponsor: JenaValve Technology, Inc.
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2018-04-20
Completion Date
2027-09-29
Last Updated
2022-11-18
Healthy Volunteers
No
Conditions
Interventions
JenaValve Pericardial TAVR System
TAVR with JenaValve Pericardial Valve and Delivery System
Locations (19)
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