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

Heart Failure Clinical Trial

— EVOLVE-MR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705312
• Other study ID #: 2019-2458
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2019
• Est. completion date: January 2022

Study information

• Verified date: October 2018
• Source: Montreal Heart Institute
• Contact: Anita W Asgar, MD
• Phone: 5143763330
• Email: anita.asgar[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Moderate functional mitral regurgitation (2+, 2-3+)

• Left ventricular ejection fraction >20%

• LVEDV 75-110 ml/m2

• Symptomatic heart failure (NYHA Class II-IV)

Exclusion Criteria:

• Left ventricular ejection fraction < 20%

• Severe functional mitral regurgitation

• Recent coronary artery bypass graft surgery (CABG)

• Untreated significant coronary artery disease

• Mitral valve area < 4.0cm2

• Severe pulmonary hypertension

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Abbott Medical Devices

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular diastolic remodelling	Change in indexed left ventricular diastolic volume (LVEDV)	12 months
Primary	Functional capacity as measured by 6 minute walk test	Change in distance walked on six-minute walk test	12 months
Secondary	Mitral regurgitation Severity (RV)	Change in mitral regurgitant volume	12 months
Secondary	Mitral regurgitation Severity (EROA)	Change in effective regurgitant orifice area	12 months
Secondary	Quality of Life Measurement	Change in indices of quality of life as measured by Kansas City Cardiomyopathy Questionnaire. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	12 months