Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

Mitral Regurgitation 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03016975
• Other study ID #: 2017-05
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: September 20, 2022

Study information

• Verified date: November 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 20, 2022
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System

Drug:
• Guideline Directed Medical Therapy
GDMT Only

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Sanger Heart & Vascular Institute - Atrium Health	Charlotte	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Pinnacle Health	Harrisburg	Pennsylvania
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia University Medical Center/New York Presbyterian Hospital	New York	New York
United States	Lenox Hill Hospital - Northwell Health	New York	New York
United States	NYU Langone Health	New York	New York
United States	Stanford University	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Providence Health &Services, Heart & Vascular Institute	Portland	Oregon
United States	St. Francis Hospital	Roslyn	New York
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Secondary Safety Endpoints [Device Group Only]	Components will be calculated with 95% confidence intervals 1. Death 2. Stroke 3. Myocardial infarction 4. Pericardial effusion requiring drainage 5. Mitral valve reintervention 6. Access site and vascular complications requiring intervention 7. Left circumflex coronary artery injury requiring intervention 8. Need for a new permanent pacemaker	30 days
Secondary	Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)	The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power. 1. MR = 1+ 2. NYHA Class 3. Kansas City Cardiomyopathy Questionnaire (KCCQ) 4. 6 Minute Walk Test (6MWT) 5. SF-36v2 Health Survey (SF-36) 6. Heart Failure Hospitalizations 7. Cardiovascular mortality	1 year
Secondary	Device Success	Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory (per device analysis).	30 days
Secondary	Procedural Success	Device success with evidence of MR reduction to = MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge (per patient analysis).	30 days
Secondary	Clinical Success	Procedural success with evidence of MR reduction = MR2+ and without MAEs* at 30 days (per patient analysis). *Major adverse events (MAE) defined as 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