Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
- Conditions
- Functional Mitral RegurgitationMitral RegurgitationMitral Insufficiency
- Interventions
- Device: Edwards Cardioband SystemDrug: Guideline Directed Medical Therapy
- Registration Number
- NCT03016975
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
- Detailed Description
The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized - Edwards Cardioband System Edwards Cardioband System Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) Randomized - Edwards Cardioband System Guideline Directed Medical Therapy Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) Randomized - Control Guideline Directed Medical Therapy Guideline directed medical therapy (GDMT) Roll-In - Edwards Cardioband System Edwards Cardioband System Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) Roll-In - Edwards Cardioband System Guideline Directed Medical Therapy Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
- Primary Outcome Measures
Name Time Method Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)]. 1 year Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).
Number of Participants With Major Adverse Events (MAE) [Device Group Only] 30 days Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention
- Secondary Outcome Measures
Name Time Method Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only) 1 year The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power. 1. MR ≤ 1+ 2. NYHA Class 3. Kansas City Cardiomyopathy Questionnaire (KCCQ) 4. 6 Minute Walk Test (6MWT) 5. SF-36v2 Health Survey (SF-36) 6. Heart Failure Hospitalizations 7. Cardiovascular mortality
Device Success 30 days Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis).
Procedural Success 30 days Device success with evidence of MR reduction to ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis).
Clinical Success 30 days Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs\* at 30 days (per patient analysis). \*Major adverse events (MAE) defined as death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention and access site and vascular complications requiring intervention.
Secondary Safety Endpoints [Device Group Only] 30 days Components will be calculated with 95% confidence intervals 1. Death 2. Stroke 3. Myocardial infarction 4. Pericardial effusion requiring drainage 5. Mitral valve reintervention 6. Access site and vascular complications requiring intervention 7. Left circumflex coronary artery injury requiring intervention 8. Need for a new permanent pacemaker
Trial Locations
- Locations (24)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Intermountain Medical Center
🇺🇸Murray, Utah, 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
St. Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Providence Health &Services, Heart & Vascular Institute
🇺🇸Portland, Oregon, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, 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
Sanger Heart & Vascular Institute - Atrium Health
🇺🇸Charlotte, North Carolina, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Pinnacle Health
🇺🇸Harrisburg, Pennsylvania, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States