Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failur… (NCT03891823) | Clinical Trial Compass
TerminatedNot Applicable
Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)
Stopped: Lack of recruitment.
Canada9 participantsStarted 2019-03-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Treatment and compliance with medical therapy for heart failure for at least 30 days;
. Clinical agreement amongst local investigators that the patient will not be offered surgical intervention;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
Exclusion criteria
. 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;