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Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) (ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016975
Recruitment Status : Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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
Functional Mitral Regurgitation Mitral Regurgitation Mitral Insufficiency Device: Edwards Cardioband System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: Transcatheter mitral valve repair (TMVr)

No Intervention: Control
Guideline directed medical therapy (GDMT)



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). [ Time Frame: 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) [ Time Frame: 30 days ]
    Rates of various adverse events (device group only)

  2. Functional improvement (NYHA Class) [ Time Frame: 1 year ]
    New York Heart Association class improvement

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

  4. Functional improvement (KCCQ) [ Time Frame: 1 year ]
    number of points improvement in KCCQ

  5. Heart failure hospitalizations [ Time Frame: 1 year ]
    number of heart failure hospitalizations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016975


  Show 24 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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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

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03016975     History of Changes
Other Study ID Numbers: 2017-05
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Edwards Lifesciences:
Edwards Cardioband
Mitral Valve
Transcatheter
Mitral repair
Functional mitral regurgitation
Secondary mitral regurgitation
Annuloplasty
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases