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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 : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE January 8, 2017
First Posted Date  ICMJE January 11, 2017
Last Update Posted Date May 7, 2020
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2018)
  • Rates of various adverse events (device group only) [ Time Frame: 30 days ]
    Rates of various adverse events (device group only)
  • Functional improvement (NYHA Class) [ Time Frame: 1 year ]
    New York Heart Association class improvement
  • Functional improvement (increase in 6 MWT distance in meters) [ Time Frame: 1 year ]
    increase in 6 MWT distance in meters
  • Functional improvement (KCCQ) [ Time Frame: 1 year ]
    number of points improvement in KCCQ
  • Heart failure hospitalizations [ Time Frame: 1 year ]
    number of heart failure hospitalizations
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Functional Mitral Regurgitation
  • Mitral Regurgitation
  • Mitral Insufficiency
Intervention  ICMJE Device: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System
Other Name: Transcatheter mitral valve repair (TMVr)
Study Arms  ICMJE
  • Experimental: Edwards Cardioband System
    Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
    Intervention: Device: Edwards Cardioband System
  • No Intervention: Control
    Guideline directed medical therapy (GDMT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 27, 2017)
375
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03016975
Other Study ID Numbers  ICMJE 2017-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Edwards Lifesciences
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP