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The JenaValve ALIGN-AR Pivotal Trial
Sponsor: JenaValve Technology, Inc.
Summary
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.
Official title: A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2020-05-22
Completion Date
2028-08
Last Updated
2022-09-13
Healthy Volunteers
No
Interventions
JenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System
Locations (30)
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
Houston Methodist
Houston, Texas, United States
Memorial Hermann - Texas Medical Center
Houston, Texas, United States
Intermountain Medical Center Heart Institute
Salt Lake City, Utah, United States
Sentara Hospitals
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States