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

• ClinicalTrials.gov Identifier: NCT03016975
• Recruitment Status: Active, not recruiting
• First Posted: January 11, 2017
• Results First Posted: November 9, 2022
• Last Update Posted: January 10, 2023
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Tracking Information

• First Submitted Date: January 8, 2017
• First Posted Date: January 11, 2017
• Results First Submitted Date: April 13, 2022
• Results First Posted Date: November 9, 2022
• Last Update Posted Date: January 10, 2023
• Actual Study Start Date: June 1, 2017
• Actual Primary Completion Date: July 19, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 14, 2022)

• 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)]. [ Time Frame: 1 year ]
  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] [ Time Frame: 30 days ]
  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

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: October 14, 2022)

• Secondary Safety Endpoints [Device Group Only] [ Time Frame: 30 days ]
  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
• Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only) [ Time Frame: 1 year ]
  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
• Device Success [ Time Frame: 30 days ]
  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 [ Time Frame: 30 days ]
  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 [ Time Frame: 30 days ]
  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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Functional Mitral Regurgitation
• Mitral Regurgitation
• Mitral Insufficiency

Intervention

• Device: Edwards Cardioband System
  Transcatheter mitral valve repair with the Edwards Cardioband System
  Other Name: Transcatheter mitral valve repair (TMVr)
• Drug: Guideline Directed Medical Therapy
  GDMT Only

Study Arms

• Experimental: Randomized - Edwards Cardioband System
  Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
  Interventions:

  • Device: Edwards Cardioband System
  • Drug: Guideline Directed Medical Therapy
• Active Comparator: Randomized - Control
  Guideline directed medical therapy (GDMT)
  Intervention: Drug: Guideline Directed Medical Therapy
• Experimental: Roll-In - Edwards Cardioband System
  Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 13, 2022): 12
• Original Enrollment: Not Provided
• Estimated Study Completion Date: September 2024
• Actual Primary Completion Date: July 19, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03016975
• Other Study ID Numbers: 2017-05
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Edwards Lifesciences
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Edwards Lifesciences
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Principal Investigator: Brian Whisenant, MD; Intermountain Medical Center
• Principal Investigator: Vinod Thourani, MD; Piedmont Heart Institute

• PRS Account: Edwards Lifesciences
• Verification Date: December 2022