Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)

NCT03891823 | Terminated

• 1 other identifier: MHICC-2018-002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The study compares the effectiveness of treatment with MitraClip to medical therapy in improving the reduction of cardiovascular morbidity and functional capacity at 24 months, in patients with moderate functional mitral regurgitation.

Conditions

Ventricular Remodeling, Left

Outcome Measures

Primary Outcomes (1)

• Change In Mitral Regurgitation

  To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in patients with moderate functional mitral regurgitation

  24 months

Secondary Outcomes (3)

• Change in Mitral Regurgitation Severity at 24 Months

  24 months

• Change in Mitral Regurgitation Severity at 12 Months

  12 months

• Change in Quality of Life Assessment

  12 months

Study Arms (2)

MitraClip

EXPERIMENTAL

Study of MitraClip in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.

Device: MitraClip; Drug: Medical Therapy

Medical Therapy

ACTIVE COMPARATOR

Study of medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.

Device: MitraClip; Drug: Medical Therapy

Interventions

MitraClip DEVICE

Study participants will be randomized to MitraClip device to determine treatment efficacy in improving LV remodelling or functional capacity.

Medical Therapy; MitraClip

Medical Therapy DRUG

Study participants will be randomized to medical therapy to determine treatment efficacy in improving LV remodelling or functional capacity.

Medical Therapy; MitraClip

Eligibility Criteria

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

You may qualify if:

• Male or female ≥18 years of age;
• Moderate (2+,2-3+) functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
• Left ventricular ejection fraction (LVEF) \>20%, as determined by transthoracic echocardiogram (TTE), and confirmed by the Echocardiography Core Lab (ECL);
• Symptomatic heart failure as defined by NYHA class II, III or ambulatory IV and NT-proBNP as follows:
• NT-proBNP \> 300 pg/mL in patients with sinus rhythm
• NT-proBNP \> 600 pg/mL in patients with atrial fibrillation
• Treatment and compliance with medical therapy for heart failure for at least 30 days;
• Optimal medical therapy is defined by:
• a. Maximum tolerated beta-blocker, angiotensin converting enzyme inhibitor (ACE) or angiotensin receptor blocker (ARB), Entresto (valsartan/sacubitril), Ivabradine and aldosterone antagonist (as per the ACC/AHA Guidelines and Canadian Cardiovascular Society Heart Failure Guidelines or other therapies (including SGLT2 inhibitors) as judged by the HF specialist investigator on site and confirmed by the Clinical Eligibility Committee.
• Clinical agreement amongst local investigators that the patient will not be offered surgical intervention;
• The primary regurgitant jet, in the opinion of the MitraClip implanting investigator, can successfully be treated by the MitraClip. Treatment of commissural mitral regurgitation may be treated at the discretion of the operator. All major jets contributing the secondary MR will be treated with the MitraClip;
• Ability to perform a six-minute walk test (6MWT) without substantial physical limitations and without use of a walker or wheelchair and distance walked in 6 minutes of ≤ 450m;
• Ability and willingness to give written informed consent and to comply with the requirements of the study.

You may not qualify if:

• Life expectancy less than 12 months due to non-cardiac conditions;
• ACC/AHA Stage D Heart Failure;
• Left ventricular ejection fraction ≤ 25%; indexed left ventricular end-diastolic volume ≥100 ml/m2;
• Severe (3-4+, 4+) secondary mitral regurgitation with an indication for intervention;
• Hypotension (systolic pressure \<90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support;
• United Network for Organ Sharing (UNOS) status 1 heart transplantation (Canadian Cardiac Transplantation Network, CCTN, status 4) or prior orthotopic heart transplantation;
• Untreated clinically significant coronary artery disease requiring revascularization;
• CABG within prior 30 days;
• Percutaneous coronary intervention within prior 30 days;
• Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy;
• Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure;
• Positive pregnancy test, or woman of child bearing potential not using highly effective methods of contraception;
• Women are considered not of childbearing potential if they:
• Have had a hysterectomy, a bilateral oophorectomy or tubal ligation prior to Baseline Visit.
• Are postmenopausal defined as no menses for at least 1 year and have a serum FSH level of 40 IU/L.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jean Rouleau, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Anique Ducharme, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

• Sophie Tanguay, MSc

  Montreal Health Innovations Coordinating Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized study of MitraClip vs. medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) functional mitral regurgitation and left ventricular dysfunction. Subjects will be followed for 24 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 24-month follow-up.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: March 8, 2019
• Primary Completion: March 28, 2024
• Study Completion: May 15, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)