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)

Status: Active, not recruiting
Location: See all (30) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Arizona
TMC HealthCare & PIMA Heart
Tucson
California
Cedars Sinai Medical Center
Los Angeles
Scripps Hospital
San Diego
California Pacific Medical Center Research Institute
San Francisco
Washington, D.c.
MedStar Washington Hospital Center
Washington
Florida
Morton Plant/ BayCare Health
Clearwater
Georgia
Emory University Hospital
Atlanta
Piedmont Healthcare
Atlanta
Illinois
Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health
Oak Lawn
Maryland
University of Maryland Medical Center
Baltimore
Michigan
University of Michigan
Ann Arbor
Henry Ford Health System
Detroit
Minnesota
Minneapolis Heart Institute/ Abbott Northwestern
Minneapolis
Missouri
Barnes-Jewish Hospital / Washington University
Saint Louis
New Jersey
Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital
Piscataway
New York
New York-Presbyterian/ Columbia University Medical Center
New York
Ohio
The Christ Hospital
Cincinnati
Cleveland Clinic Foundation
Cleveland
Ohio Health Research Institute
Columbus
Oregon
Oregon Health & Science University
Portland
Pennsylvania
Allegheny-Singer Health Network
Pittsburgh
Lankenau
Wynnewood
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Methodist Le Bonheur Healthcare
Memphis
Texas
Baylor Scott & White Research Institute
Dallas
Houston Methodist
Houston
Memorial Hermann - Texas Medical Center
Houston
Utah
Intermountain Medical Center Heart Institute
Salt Lake City
Virginia
Sentara Hospitals
Norfolk
Washington
University of Washington
Seattle
Time Frame
Start Date: May 22, 2020
Estimated Completion Date: August 2028
Participants
Target number of participants: 180
Treatments
Experimental: Transcatheter Aortic Valve Replacement (TAVR)
TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System
Authors
James McCabe, Brian Whisenant, Ravi Ramana, Stanley J. Chetcuti, Thomas Waggoner, Dean Kereiakes, Steven J Yakubov, Ron Waksman, Nicholas Amoroso, Philippe Généreux, Samir Kapadia, Susheel Kodali, Mark J. Russo, Sukhdeep Basra, Molly Szerlip, Michael Reardon, Firas Zahr, Vinod H. Thourani, Joshua Rovin, Torsten P. Vahl, Vivek Rajagopal, Adam B. Greenbaum, Stephan Baldus, David V. Daniels, Anuj Gupta, Tom Waggoner, Christopher U. Meduri, Paul Sorajja, Raj Makkar
Sponsors
Leads: JenaValve Technology, Inc.

This content was sourced from clinicaltrials.gov

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