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 range18 Years
SexALL
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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;
✓. 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;
. 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;