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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active heart infection or rheumatic heart disease.I am not pregnant and use effective birth control methods.My heart valve's shape or condition might not allow for a specific clip placement.I have moderate heart valve leakage due to heart muscle disease, confirmed by a heart ultrasound.My heart has high pressure or is affected by a disease that thickens its walls.I have severe leakage in my heart's mitral valve needing treatment.You are not expected to live for more than 12 months because of non-heart-related health issues.My heart failure is classified as severe.My heart's pumping ability is very low and it's larger than normal.I need blood transfusions or medication to manage my severe anemia.I have a heart condition that hasn't been treated but needs surgery.I am currently on antibiotics for an infection.Your heart's pumping function, as measured by a special ultrasound test, must be greater than 20%.My doctors agree that surgery is not an option for me.I am on the urgent list for a heart transplant or have had one before.My kidney function is severely impaired, with an eGFR below 30.You should not have trans-esophageal echocardiography or have a high risk for it.I had a heart bypass surgery within the last 30 days.I have severe heart issues on the right side, confirmed by an echo test.I have had surgery or a procedure on my mitral valve before.I can walk for six minutes without help but can't go over 450 meters.I do not need any urgent surgery or have any planned heart surgery in the next year.You have a severe disability with a score greater than 4 on the Modified Rankin Scale.I have not had a stroke or mini-stroke in the last 30 days.I need daily oxygen or steroids for my severe COPD.I have heart failure symptoms and my NT-proBNP levels are high.I had a procedure to open my heart's arteries within the last 30 days.I need surgery for a serious heart valve issue.I have low blood pressure or need support to maintain my blood circulation.My heart valve issue is considered treatable with the MitraClip according to my doctor.You have signs of a mass, blood clot, or infection in your heart when checked with an echocardiogram.I have been treating my heart failure and following my doctor's advice for at least 30 days.I need surgery or a catheter-based procedure for my aortic valve condition.Your mitral valve area is smaller than 4.0 cm2 when measured by a specific method.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Medical Therapy
- Group 2: MitraClip
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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