Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

Stopped early · Not applicable

Conditions studied: Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency

In brief

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

Key facts

Study ID

NCT03016975

Run by

Edwards Lifesciences

People needed

12

Starts

2017-06-01

Expected to finish

2022-09-20

Last updated by the study team

2023-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Primarily degenerative MR;
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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