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Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) (ACTIVE)

Primary Purpose

Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Edwards Cardioband System
Guideline Directed Medical Therapy
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Edwards Cardioband, Mitral Valve, Transcatheter, Mitral repair, Functional mitral regurgitation, Secondary mitral regurgitation, Annuloplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Stanford University
  • University of Colorado Denver
  • MedStar Washington Hospital Center
  • Emory University Hospital
  • Northwestern University
  • St. Vincent Heart Center
  • Beth Israel Deaconess Medical Center
  • Henry Ford Hospital
  • Morristown Medical Center
  • NYU Langone Health
  • Columbia University Medical Center/New York Presbyterian Hospital
  • Lenox Hill Hospital - Northwell Health
  • St. Francis Hospital
  • Sanger Heart & Vascular Institute - Atrium Health
  • The Cleveland Clinic Foundation
  • Providence Health &Services, Heart & Vascular Institute
  • Oregon Health & Science University
  • Pinnacle Health
  • Hospital of the University of Pennsylvania
  • The University of Texas Health Science Center at Houston
  • The Heart Hospital Baylor Plano
  • Intermountain Medical Center
  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Randomized - Edwards Cardioband System

Randomized - Control

Roll-In - Edwards Cardioband System

Arm Description

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

Guideline directed medical therapy (GDMT)

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

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

Secondary Safety Endpoints [Device Group Only]
Components will be calculated with 95% confidence intervals Death Stroke Myocardial infarction Pericardial effusion requiring drainage Mitral valve reintervention Access site and vascular complications requiring intervention Left circumflex coronary artery injury requiring intervention Need for a new permanent pacemaker
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. MR ≤ 1+ NYHA Class Kansas City Cardiomyopathy Questionnaire (KCCQ) 6 Minute Walk Test (6MWT) SF-36v2 Health Survey (SF-36) Heart Failure Hospitalizations Cardiovascular mortality
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).
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).
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.

Full Information

First Posted
January 8, 2017
Last Updated
December 13, 2022
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03016975
Brief Title
Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)
Acronym
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Insufficiency
Keywords
Edwards Cardioband, Mitral Valve, Transcatheter, Mitral repair, Functional mitral regurgitation, Secondary mitral regurgitation, Annuloplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized - Edwards Cardioband System
Arm Type
Experimental
Arm Description
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Arm Title
Randomized - Control
Arm Type
Active Comparator
Arm Description
Guideline directed medical therapy (GDMT)
Arm Title
Roll-In - Edwards Cardioband System
Arm Type
Experimental
Arm Description
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
Intervention Type
Device
Intervention Name(s)
Edwards Cardioband System
Other Intervention Name(s)
Transcatheter mitral valve repair (TMVr)
Intervention Description
Transcatheter mitral valve repair with the Edwards Cardioband System
Intervention Type
Drug
Intervention Name(s)
Guideline Directed Medical Therapy
Intervention Description
GDMT Only
Primary Outcome Measure Information:
Title
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)].
Description
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).
Time Frame
1 year
Title
Number of Participants With Major Adverse Events (MAE) [Device Group Only]
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoints [Device Group Only]
Description
Components will be calculated with 95% confidence intervals Death Stroke Myocardial infarction Pericardial effusion requiring drainage Mitral valve reintervention Access site and vascular complications requiring intervention Left circumflex coronary artery injury requiring intervention Need for a new permanent pacemaker
Time Frame
30 days
Title
Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)
Description
The following key secondary efficacy endpoints will be tested in comparison to control in a hierarchical order to preserve statistical power. MR ≤ 1+ NYHA Class Kansas City Cardiomyopathy Questionnaire (KCCQ) 6 Minute Walk Test (6MWT) SF-36v2 Health Survey (SF-36) Heart Failure Hospitalizations Cardiovascular mortality
Time Frame
1 year
Title
Device Success
Description
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).
Time Frame
30 days
Title
Procedural Success
Description
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).
Time Frame
30 days
Title
Clinical Success
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Whisenant, MD
Organizational Affiliation
Intermountain Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinod Thourani, MD
Organizational Affiliation
Piedmont Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Vincent Heart Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lenox Hill Hospital - Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Sanger Heart & Vascular Institute - Atrium Health
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence Health &Services, Heart & Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pinnacle Health
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

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