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

U

University of Montreal

Status

Unknown

Conditions

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

Treatments

Other: Guideline-directed medical therapy
Device: Transcatheter mitral valve repair

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03705312
2019-2458

Details and patient eligibility

About

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.

Full 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.

Enrollment

174 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

174 participants in 2 patient groups, including a placebo group

Guideline-directed medical therapy
Placebo Comparator group
Description:
Standard guideline-directed medical treatment for heart failure
Treatment:
Other: Guideline-directed medical therapy
Transcatheter Mitral valve repair
Experimental group
Description:
MitraClip treatment
Treatment:
Device: Transcatheter mitral valve repair

Trial contacts and locations

1

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Central trial contact

Anita W Asgar, MD

Data sourced from clinicaltrials.gov

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