NCT03705312

MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR

EValuation of Outcomes of Transcatheter Mitral Valve Repair for the Treatment of Low Ejection Fraction and Moderate Functional Mitral ValvE Regurgitation In Heart Failure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.

Detailed description

Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients. Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation, improve symptoms and result in LV remodelling. At present, the optimal treatment strategy for heart failure patients and moderate (2+, 2-3+) mitral regurgitation is uncertain therefore the EVOLVE-MR study proposes to evaluate transcatheter mitral valve repair with the MitraClip in such patients to study the effects on LV remodelling and functional capacity. EVOLVE-MR is a randomized study of MitraClip and medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) secondary mitral regurgitation. The objective of this study is to determine the impact of both therapies on left ventricular remodelling and functional capacity of the target patient population.

Conditions

• Mitral Regurgitation
• Heart Failure
• Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)

Interventions

Type	Name	Description
DEVICE	Transcatheter mitral valve repair	Transcatheter mitral valve repair performed using the MitraClip device
OTHER	Guideline-directed medical therapy	Standard medical therapy for heart failure as recommended by HF guidelines

Timeline

• Start date: 2019-02-22
• Primary completion: 2021-12-01
• Completion: 2022-01-01
• First posted: 2018-10-15
• Last updated: 2019-08-14

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study