Clinical trial NCT03016975: Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Functional Mitral Regurgitation
Mitral Regurgitation
Mitral Insufficiency
Keywords: Edwards Cardioband
Mitral Valve
Transcatheter
Mitral repair
Functional mitral regurgitation
Secondary mitral regurgitation
Annuloplasty
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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)].
timeFrame: 1 year
measure: Number of Participants With Major Adverse Events (MAE) [Device Group Only]
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Safety Endpoints [Device Group Only]
timeFrame: 30 days
measure: Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)
timeFrame: 1 year
measure: Device Success
timeFrame: 30 days
measure: Procedural Success
timeFrame: 30 days
measure: Clinical Success
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital - Northwell Health
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute - Atrium Health
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence Health &Services, Heart & Vascular Institute
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Intermountain Medical Center
name: Brian Whisenant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Heart Institute
name: Vinod Thourani, MD
role: PRINCIPAL_INVESTIGATOR
References: