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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)
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.
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
April 20, 2018
Primary Completion Date
August 29, 2022
Completion Date
September 29, 2027
Last Updated
November 18, 2022
100
ESTIMATED participants
JenaValve Pericardial TAVR System
DEVICE
Lead Sponsor
JenaValve Technology, Inc.
NCT07075861
NCT07398911
NCT04671758
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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