Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

Edwards Lifesciences

Status: Terminated

Conditions: Functional Mitral Regurgitation; Mitral Insufficiency; Mitral Regurgitation

Treatments: Device: Edwards Cardioband System; Drug: Guideline Directed Medical Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03016975

2017-05

Details and patient eligibility

About

To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Randomized - Edwards Cardioband System

Experimental group

Description:

Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)

Treatment:

Drug: Guideline Directed Medical Therapy

Device: Edwards Cardioband System

Randomized - Control

Active Comparator group

Description:

Guideline directed medical therapy (GDMT)

Treatment:

Drug: Guideline Directed Medical Therapy

Roll-In - Edwards Cardioband System

Experimental group

Description:

Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)

Treatment:

Drug: Guideline Directed Medical Therapy

Device: Edwards Cardioband System