Clinical trial
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
Name
2017-05
Description
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
Trial arms
Trial start
2017-06-01
Estimated PCD
2019-07-19
Trial end
2022-09-20
Status
Terminated
Treatment
Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System
Arms:
Randomized - Edwards Cardioband System, Roll-In - Edwards Cardioband System
Other names:
Transcatheter mitral valve repair (TMVr)
Guideline Directed Medical Therapy
GDMT Only
Arms:
Randomized - Control, Randomized - Edwards Cardioband System, Roll-In - Edwards Cardioband System
Size
12
Primary endpoint
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)].
1 year
Number of Participants With Major Adverse Events (MAE) [Device Group Only]
30 days
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2023-11-30
1 organization
1 product
3 indications
Indication
Mitral RegurgitationIndication
Mitral Valve RegurgitationIndication
Mitral Valve InsufficiencyOrganization
Edwards Lifesciences