Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891823
Recruitment Status : Active, not recruiting
First Posted : March 27, 2019
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
Montreal Heart Institute

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 12 months, in patients with moderate functional mitral regurgitation.

Condition or disease Intervention/treatment Phase
Ventricular Remodeling, Left Device: MitraClip Drug: Medical Therapy Not Applicable

Detailed Description:

Primary Objective To compare the effectiveness of treatment with MitraClip to medical therapy in improving left ventricular remodelling (indexed left ventricular end-diastolic volume,(LVEDVi)) and functional capacity (distance walked on a 6MWT) at 12 months, in patients with moderate functional mitral regurgitation Secondary Objectives

  • To evaluate the effects of MitraClip and medical therapy on change from baseline in mitral regurgitation severity at 12 months
  • To evaluate the effects of MitraClip and medical therapy on change from baseline in quality of life at 12 months Exploratory Objectives To evaluate the effects of MitraClip and medical therapy on functional class, biomarkers, clinical events, parameters of physical activity, echocardiographic parameters and health economic assessments.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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 12 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 12-month follow-up.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EValuation of Outcomes of MitraClip for the Treatment of Low Ejection Fraction and MODERATE Functional Mitral ValvE Regurgitation in Heart Failure
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: MitraClip

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 12 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 12-month follow-up.

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

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

Active Comparator: Medical Therapy

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 12 months and there will be one formal interim analysis for futility after approximately 50% of subjects have completed their 12-month follow-up.

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

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




Primary Outcome Measures :
  1. Change In Mitral Regurgitation [ Time Frame: 12 months ]
    Change in mitral regurgitation severity from baseline to 12 months

  2. Improvement in Distance Walked [ Time Frame: 12 months ]
    Improvement in distance walked on a six-minute walk test (6MWT) from baseline to 12 monthsbaseline to 12 months


Secondary Outcome Measures :
  1. Change in mitral regurgitation severity [ Time Frame: 12 months ]
    Change in mitral regurgitation severity from baseline to 12 months

  2. Change in Quality of Life Assessment [ Time Frame: 12 months ]
    Change in Quality of Life Assessment, Kansas City Cardiomyopathy Questionnaire (KCCQ), from baseline to 12 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Study participants must meet ALL of the following inclusion criteria in order to be eligible for this study:

    1. 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);
    2. Left ventricular ejection fraction > 20%, as assessed by any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI) and evidence of LV dilatation defined as a baseline LVEDV of 75-110 ml/m2 measured by echocardiography;
    3. Symptomatic heart failure as defined by NYHA class II, III or ambulatory IV and NT-pro BNP > 800ug/mL (sinus rhythm) or 1000ug/mL (AFIB);
    4. 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/sacubatril) and aldosterone antagonist (as per the ACC/AHA Guidelines as judged by the HF specialist investigator on site and confirmed by the Central Eligibility Committee).

    5. Clinical agreement amongst local investigators that the patient will not be offered surgical intervention;
    6. 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;
    7. 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;
    8. Ability and willingness to give written informed consent and to comply with the requirements of the study.

Exclusion Criteria:

  • Study participants meeting any of the following exclusion criteria by the day of randomization (visit 2) are NOT eligible for this study:

    1. Life expectancy less than 12 months due to noncardiac conditions;
    2. ACC/AHA Stage D Heart Failure;
    3. Left ventricular ejection fraction ≤ 20%; indexed left ventricular end-diastolic volume > 110ml/m2
    4. Severe (3-4+, 4+) secondary mitral regurgitation with an indication for intervention
    5. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support;
    6. United Network for Organ Sharing (UNOS) status 1 heart transplantation (Canadian Cardiac Transplantation Network, CCTN, status 4) or prior orthotopic hear transplantation;
    7. Untreated clinically significant coronary artery disease requiring revascularization;
    8. CABG within prior 30 days;
    9. Percutaneous coronary intervention within prior 30 days;
    10. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring continuous daytime home oxygen or chronic oral corticosteroid therapy;
    11. Previous surgical mitral valve bioprosthesis, mitral annuloplasty, or transcatheter mitral valve procedure;
    12. Positive pregnancy test, or woman of child bearing potential not using highly effective methods of contraception;
    13. Mitral valve area <4.0 cm2 as assessed by planimetry of the mitral valve;
    14. Subjects in whom trans-esophageal echocardiography is contraindicated or high risk;
    15. Mitral leaflet anatomy which may preclude MitraClip implantation:

      1. Perforated mitral leaflets or clefts, lack of primary or secondary chordal support;
      2. Severe calcification in the grasping area;
      3. Rheumatic valve disease.
    16. Stroke or transient ischemic event within 30 days before randomization;
    17. Modified Rankin Scale >4 disability;
    18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months;
    19. Severe renal impairment defined as an Estimated Glomelular Filtration Rate (eGFR) <30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula;
    20. Severe anemia requiring transfusional support or therapy with erythropoietin;
    21. Physical evidence of uncontrolled right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction;
    22. Aortic valve disease requiring surgery or transcatheter intervention;
    23. Significant tricuspid valve disease requiring surgical intervention or very severe tricuspid regurgitation with evidence of right ventricular dysfunction;
    24. Active infection requiring antibiotic therapy;
    25. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease;
    26. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
    27. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits;
    28. Presence of any of the following:

      1. Pulmonary artery systolic pressure (PASP) > 70 mm Hg confirmed by right heart catheterization;
      2. Infiltrative cardiomyopathies.
    29. Any other condition(s) that would compromise the safety of the patient as judged by the site principal investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891823


Locations
Layout table for location information
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Montreal Health Innovations Coordinating Center
Montréal, Quebec, Canada, H1Y 3N1
Sponsors and Collaborators
Montreal Heart Institute
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Jean Rouleau, MD Montreal Heart Institute
Study Director: Andreas Orfanos, MD Montreal Health Innovations Coordinating Centre
Layout table for additonal information
Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT03891823    
Other Study ID Numbers: MHICC-2018-002
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Mitral Valve Insufficiency
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases