Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System and GDMT vs GDMT Alone in Patients With FMR and Heart Failure
Status: Terminated
Location: See all (24) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age \> 18 years;
• Clinically Significant Functional Mitral Regurgitation (MR);
• Symptomatic heart failure;
• Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
• Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.
Locations
United States
California
Cedars-Sinai Medical Center
Los Angeles
Stanford University
Palo Alto
Colorado
University of Colorado Denver
Aurora
Washington, D.c.
MedStar Washington Hospital Center
Washington
Georgia
Emory University Hospital
Atlanta
Illinois
Northwestern University
Chicago
Indiana
St. Vincent Heart Center
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Michigan
Henry Ford Hospital
Detroit
North Carolina
Sanger Heart & Vascular Institute - Atrium Health
Charlotte
New Jersey
Morristown Medical Center
Morristown
New York
Columbia University Medical Center/New York Presbyterian Hospital
New York
Lenox Hill Hospital - Northwell Health
New York
NYU Langone Health
New York
St. Francis Hospital
Roslyn
Ohio
The Cleveland Clinic Foundation
Cleveland
Oregon
Oregon Health & Science University
Portland
Providence Health &Services, Heart & Vascular Institute
Portland
Pennsylvania
Pinnacle Health
Harrisburg
Hospital of the University of Pennsylvania
Philadelphia
Texas
The University of Texas Health Science Center at Houston
Houston
The Heart Hospital Baylor Plano
Plano
Utah
Intermountain Medical Center
Murray
Virginia
University of Virginia Health System
Charlottesville
Time Frame
Start Date: 2017-06-01
Completion Date: 2022-09-20
Participants
Target number of participants: 12
Treatments
Experimental: Randomized - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Active_comparator: Randomized - Control
Guideline directed medical therapy (GDMT)
Experimental: Roll-In - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Authors
Marc Gillinov, Santanu Biswas, S. Chris Malaisrie, Torin Fitton, Brian Whisenant, Kamal Khabbaz, Ernesto Salcedo, Randall Starling, Konstantinos Koulogiannis, Nimesh Desai, Brandon Jones, Cezar Staniloae, Pranav Loyalka, Igor Gregoric, James Hermiller, Mubashir Mumtaz, Stephanie Mick, Alan Yeung, S. Jacob Scheinerman, Jeffrey Popma, Tamim Nazif, Andreas Brieke, Albert Cheung, Hassan Nemeh, Ethan Korngold, William Hiesinger, John Kern, James Mudd, Marek Polomsky, Eric Kirker, Samir Kapadia, Warren Manning, Susheel Kodali, James Lee, Robert Kipperman, Neil Bercow, Omar Khalique, Frank Silvestry, Marwa Sabe, Jeffrey Swanson, Paul Grayburn, John Messenger, Martin Leon, Charles Davidson, Chad Kliger, Eric Skipper, Joseph Cleveland, Marc Goldschmidt, Abhijeet Dhoble, John Dent, Vasilis Babaliaros, Firas Zahr, William Downey, Vinod Thourani, Michael Rinaldi, Gary Ott, Robert Hodson, D. Scott Lim, John Frederick, David Heimansohn, James Flaherty, Duane Pinto, David Fullerton, Hemal Gada, Stamatios Lerakis, Mazen Hanna, Howard Herrmann, Louis Chu, Scott Chadderdon, David Liu, John Brown III, George Petrossian, Ambarish Gopal, Patrick Norton, Kent Jones, Mark Ricciardi, Roger Laham, Rebecca Hahn, Luigi Pirelli, Sina Moainie, Robert Smith, Edward Gill, Jack Boyd, Gregory Elsner, Gaetano Paone, Marvin Eng, Shinya Unai, Cristina Fuss, Andrew Berke, Robert Guyton, Bryan Zweig, Feroze Mahmood, Harold Litt, Leo Marcoff, Adam Greenbaum, Gorav Ailawadi, Ron Waksman, Christian Shults, Richard Smalling, James Harkness, Lowell Satler, Amar Krishnaswamy, Seth Uretsky, Itsik Ben-Dor
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences