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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03705312
Other study ID # 2019-2458
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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