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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
Results First Posted : November 9, 2022
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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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 Drug: Guideline Directed Medical Therapy 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 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
Actual Primary Completion Date : July 19, 2019
Estimated Study Completion Date : September 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Randomized - 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)

Drug: Guideline Directed Medical Therapy
GDMT Only
Active Comparator: Randomized - Control
Guideline directed medical therapy (GDMT)
 Drug: Guideline Directed Medical Therapy
GDMT Only
Experimental: Roll-In - 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)

Drug: Guideline Directed Medical Therapy
GDMT Only


Outcome Measures
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Primary Outcome Measures :
  1. 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)]. [ Time Frame: 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).

  2. Number of Participants With Major Adverse Events (MAE) [Device Group Only] [ Time Frame: 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 :
  1. Secondary Safety Endpoints [Device Group Only] [ Time Frame: 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

  2. Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only) [ Time Frame: 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

  3. Device Success [ Time Frame: 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).

  4. Procedural Success [ Time Frame: 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).

  5. Clinical Success [ Time Frame: 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.



Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Brian Whisenant, MD Intermountain Medical Center
Principal Investigator: Vinod Thourani, MD Piedmont Heart Institute
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
Study Protocol  [PDF] April 20, 2018
Statistical Analysis Plan  [PDF] February 28, 2019

More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03016975    
Other Study ID Numbers: 2017-05
First Posted: January 11, 2017    Key Record Dates
Results First Posted: November 9, 2022
Last Update Posted: January 10, 2023
Last Verified: December 2022
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
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