Clinical trial NCT03705312: MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mitral Regurgitation
Heart Failure
Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)
Keywords: mitral regurgitation
transcatheter mitral valve repair
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2018-10-15
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 1:1 to medical treatment or intervention with the MitraClip device
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular diastolic remodelling
timeFrame: 12 months
measure: Functional capacity as measured by 6 minute walk test
timeFrame: 12 months
Secondary outcomes:
measure: Mitral regurgitation Severity (RV)
timeFrame: 12 months
measure: Mitral regurgitation Severity (EROA)
timeFrame: 12 months
measure: Quality of Life Measurement
timeFrame: 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Anita W Asgar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute
name: Anique Ducharme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute
name: Jean L Rouleau, MD
role: STUDY_CHAIR
References: