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Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

Sponsor
Edwards Lifesciences (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03016975
Collaborator
(none)
375
Enrollment
24
Locations
2
Arms
87
Anticipated Duration (Months)
15.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Edwards Cardioband System
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
375 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Edwards Cardioband System

Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)

Device: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System
Other Names:
  • Transcatheter mitral valve repair (TMVr)

    		•
    No Intervention: Control

    Guideline directed medical therapy (GDMT)

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of MR ≤ 2+ and hierarchical comparison of device and control groups including time to cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved). [1 year]

      Prevalence of MR ≤ 2+ and hierarchical comparison of device and control groups

    Secondary Outcome Measures

    1. Rates of various adverse events (device group only) [30 days]

      Rates of various adverse events (device group only)

    2. Functional improvement (NYHA Class) [1 year]

      New York Heart Association class improvement

    3. Functional improvement (increase in 6 MWT distance in meters) [1 year]

      increase in 6 MWT distance in meters

    4. Functional improvement (KCCQ) [1 year]

      number of points improvement in KCCQ

    5. Heart failure hospitalizations [1 year]

      number of heart failure hospitalizations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048
    2 Stanford University Palo Alto California United States 94304
    3 University of Colorado Denver Aurora Colorado United States 80045
    4 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    5 Emory University Hospital Atlanta Georgia United States 30322
    6 Northwestern University Chicago Illinois United States 60611
    7 St. Vincent Heart Center Indianapolis Indiana United States 46290
    8 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    9 Henry Ford Hospital Detroit Michigan United States 48202
    10 Morristown Medical Center Morristown New Jersey United States 07960
    11 NYU Langone Health New York New York United States 10016
    12 Columbia University Medical Center/New York Presbyterian Hospital New York New York United States 10032
    13 Lenox Hill Hospital - Northwell Health New York New York United States 10075
    14 St. Francis Hospital Roslyn New York United States 11576
    15 Sanger Heart & Vascular Institute - Atrium Health Charlotte North Carolina United States 28203
    16 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
    17 Providence Health &Services, Heart & Vascular Institute Portland Oregon United States 97225
    18 Oregon Health & Science University Portland Oregon United States 97239
    19 Pinnacle Health Harrisburg Pennsylvania United States 17101
    20 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    21 The University of Texas Health Science Center at Houston Houston Texas United States 77030
    22 The Heart Hospital Baylor Plano Plano Texas United States 75093
    23 Intermountain Medical Center Murray Utah United States 84107
    24 University of Virginia Health System Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • Edwards Lifesciences

    Investigators

    • Study Chair: Mark Reisman, MD, University of Washington
    • Principal Investigator: Brian Whisenant, MD, Intermountain Medical Center
    • Principal Investigator: Vinod Thourani, MD, Medstar Washington Hospital Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Edwards Lifesciences
    ClinicalTrials.gov Identifier:
    NCT03016975
    Other Study ID Numbers:
    • 2017-05
    First Posted:
    Jan 11, 2017
    Last Update Posted:
    Jun 11, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Edwards Lifesciences
    Edwards Cardioband
    Mitral Valve
    Transcatheter
    Mitral repair
    Functional mitral regurgitation
    Secondary mitral regurgitation
    Annuloplasty
    Additional relevant MeSH terms:
    Mitral Valve Insufficiency

    Study Results

    No Results Posted as of Jun 11, 2020