NCT03891823

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

EValuation of Outcomes of MitraCLip for the Treatment of Moderate Functional Mitral ValvE Regurgitation In Heart Failure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective To compare the effectiveness of treatment with MitraClip to medical therapy on the change from baseline to 24 months in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score 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 24 months. * 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 in quality of life from baseline to 12 months, as measured by the KCCQ. Tertiary Objectives * To evaluate the effects of MitraClip and medical therapy on change from baseline in functional capacity (distance walked on a 6MWT) at 12 and 24 Months. * To evaluate the effects of MitraClip and medical therapy on change from baseline in quality of life, as measured by the EQ5DL questionnaire, at 12 and 24 months. * To evaluate the effects of MitraClip and medical therapy on freedom from progression to severe MR at 24 months as assessed by echocardiography. * To evaluate the effects of MitraClip and medical therapy on change from baseline in LVEDVi at 24 months. Exploratory Objectives * To evaluate the effects of MitraClip and medical therapy on functional class, biomarkers, clinical events, parameters of physical activity, other echocardiographic parameters and health economic assessments. * To evaluate the effects of MitraClip and medical therapy on all hospitalizations for decompensated heart failure, including episodes of outpatient treatment intensification in a HF clinic or emergency department visits, at 24 months.

Conditions

• Ventricular Remodeling, Left

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-08
• Primary completion: 2024-03-28
• Completion: 2024-05-15
• First posted: 2019-03-27
• Last updated: 2024-05-30

Locations

1 site across 1 country: Canada