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

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ClinicalTrials.gov Identifier: NCT03016975
Recruitment Status : Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

January 8, 2017
January 11, 2017
December 4, 2018
June 1, 2017
September 2020   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT03016975 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
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
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Functional Mitral Regurgitation
  • Mitral Regurgitation
  • Mitral Insufficiency
Device: Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System
Other Name: Transcatheter mitral valve repair (TMVr)
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
375
Not Provided
September 2024
September 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03016975
2017-05
Yes
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
Plan to Share IPD: Undecided
Edwards Lifesciences
Edwards Lifesciences
Not Provided
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
Edwards Lifesciences
December 2018

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