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Device

Transcatheter Mitral Valve Repair for Heart Failure (EVOLVE-MR Trial)

N/A
Recruiting
Led By Jean Rouleau, MD
Research Sponsored by Montreal Heart Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Clinical agreement amongst local investigators that the patient will not be offered surgical intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

EVOLVE-MR Trial Summary

This trial found that the MitraClip was more effective than medical therapy in reducing cardiovascular morbidity and functional capacity.

Who is the study for?
Adults over 18 with heart failure and moderate mitral regurgitation due to cardiomyopathy, who can walk for six minutes but not more than 450m. They must have been on stable heart failure medication for at least a month, have an ejection fraction over 20%, and be symptomatic as defined by specific criteria. Excluded are those with severe coronary disease needing intervention, recent stroke or surgery, certain valve diseases, severe kidney impairment, life expectancy under a year from non-cardiac causes, or women who could become pregnant.Check my eligibility
What is being tested?
The EVOLVE-MR trial is testing whether the MitraClip device is better than medical therapy alone in reducing heart problems and improving exercise capacity in patients with functional mitral regurgitation after two years. Patients will either receive the MitraClip procedure or continue with their usual medications.See study design
What are the potential side effects?
Possible side effects of the MitraClip include bleeding complications, infection risk at the catheter insertion site, potential damage to the mitral valve requiring surgery, irregular heartbeats (arrhythmias), and risks associated with sedation such as allergic reactions.

EVOLVE-MR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate heart valve leakage due to heart muscle disease, confirmed by a heart ultrasound.
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My doctors agree that surgery is not an option for me.
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I can walk for six minutes without help but can't go over 450 meters.
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I have heart failure symptoms and my NT-proBNP levels are high.
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My heart valve issue is considered treatable with the MitraClip according to my doctor.
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I have been treating my heart failure and following my doctor's advice for at least 30 days.
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I am 18 years old or older.

EVOLVE-MR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change In Mitral Regurgitation
Secondary outcome measures
Change in Mitral Regurgitation Severity at 12 Months
Change in Mitral Regurgitation Severity at 24 Months
Change in Quality of Life Assessment

EVOLVE-MR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MitraClipExperimental Treatment2 Interventions
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.
Group II: Medical TherapyActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MitraClip
2017
N/A
~2040
Medical Therapy
2015
N/A
~3100

Find a Location

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
120 Previous Clinical Trials
68,595 Total Patients Enrolled
Abbott Medical DevicesIndustry Sponsor
635 Previous Clinical Trials
403,787 Total Patients Enrolled
Sophie Tanguay, MScStudy DirectorMontreal Health Innovations Coordinating Centre

Media Library

MitraClip (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03891823 — N/A
Left Ventricular Remodeling Research Study Groups: Medical Therapy, MitraClip
Left Ventricular Remodeling Clinical Trial 2023: MitraClip Highlights & Side Effects. Trial Name: NCT03891823 — N/A
MitraClip (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03891823 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase for this clinical trial still active?

"Per the information accessible on clinicaltrials.gov, recruitment for this study is ongoing. The trial was introduced to the public on March 8th 2019 and has been edited as recently as August 26th 2022."

Answered by AI

What is the exact number of participants involved in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical experiment is actively looking for participants; it was initially posted on March 8th 2019 and most recently modified on August 26th 2022. The trial requires a total of 224 patients recruited from 1 site."

Answered by AI
~35 spots leftby Mar 2025