Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
NCT ID: NCT03016975
Last Updated: 2023-11-30
Study Results
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View full resultsBasic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2017-06-01
2022-09-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Randomized - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System
Guideline Directed Medical Therapy
GDMT Only
Randomized - Control
Guideline directed medical therapy (GDMT)
Guideline Directed Medical Therapy
GDMT Only
Roll-In - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System
Guideline Directed Medical Therapy
GDMT Only
Interventions
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Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System
Guideline Directed Medical Therapy
GDMT Only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Mitral annular calcification that would impede implantation of device;
* Other severe valve disorders requiring intervention;
* Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;
* Life expectancy of less than twelve months;
* Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint;
* Unwillingness or inability to undergo follow-up investigations/visits;
* Other medical, social, or psychological conditions that precludes appropriate consent and follow-up
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Whisenant, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Vinod Thourani, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of Colorado Denver
Aurora, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
St. Vincent Heart Center
Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Morristown Medical Center
Morristown, New Jersey, United States
NYU Langone Health
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Lenox Hill Hospital - Northwell Health
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Sanger Heart & Vascular Institute - Atrium Health
Charlotte, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Providence Health &Services, Heart & Vascular Institute
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-05
Identifier Type: -
Identifier Source: org_study_id