Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

NCT03016975 | Terminated Results DMC FDA Device

• 1 other identifier: 2017-05
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 24

Brief Summary

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

Conditions

Functional Mitral Regurgitation; Mitral Regurgitation; Mitral Insufficiency

Keywords

Edwards Cardioband; Mitral Valve; Transcatheter; Mitral repair; Functional mitral regurgitation; Secondary mitral regurgitation; Annuloplasty

Outcome Measures

Primary Outcomes (2)

• 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)].

  Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and 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]

  Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention

  30 days

Secondary Outcomes (5)

• Secondary Safety Endpoints [Device Group Only]

  30 days

• Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)

  1 year

• Device Success

  30 days

• Procedural Success

  30 days

• Clinical Success

  30 days

Study Arms (3)

Randomized - Edwards Cardioband System

EXPERIMENTAL

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

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

Randomized - Control

ACTIVE COMPARATOR

Guideline directed medical therapy (GDMT)

Drug: Guideline Directed Medical Therapy

Roll-In - Edwards Cardioband System

EXPERIMENTAL

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

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

Interventions

Edwards Cardioband System DEVICE

Transcatheter mitral valve repair with the Edwards Cardioband System

Also known as: Transcatheter mitral valve repair (TMVr)

Randomized - Edwards Cardioband System; Roll-In - Edwards Cardioband System

Guideline Directed Medical Therapy DRUG

GDMT Only

Randomized - Control; Randomized - Edwards Cardioband System; Roll-In - Edwards Cardioband System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (24)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

St. Vincent Heart Center

Indianapolis, Indiana, 46290, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Lenox Hill Hospital - Northwell Health

New York, New York, 10075, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Sanger Heart & Vascular Institute - Atrium Health

Charlotte, North Carolina, 28203, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Providence Health &Services, Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Pinnacle Health

Harrisburg, Pennsylvania, 17101, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ted Feldman
• Organization: Edwards Lifesciences

Feldman_Info@edwards.com

949-250-2500

Study Officials

• Brian Whisenant, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

• Vinod Thourani, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2017
• First Posted: January 11, 2017
• Study Start: June 1, 2017
• Primary Completion: July 19, 2019
• Study Completion: September 20, 2022
• Last Updated: November 30, 2023
• Results First Posted: November 9, 2022

Record last verified: 2023-11

Locations

US (24)