Recruiting

MitraClip

Sponsor:

Montreal Heart Institute

Code:

NCT03705312

Conditions

Mitral Regurgitation

Heart Failure

Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcatheter mitral valve repair

Guideline-directed medical therapy

Study Details

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.

Conditions

Mitral Regurgitation

Heart Failure

Mitral Valve Regurgitation Due to Cardiomyopathy (Disorder)

Study ID

NCT03705312

Start date

Feb 22, 2019

Status verified date

Oct, 2018

Completion date

Jan, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

174 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Guideline-directed medical therapy

Standard guideline-directed medical treatment for heart failure

experimental: Transcatheter Mitral valve repair

MitraClip treatment

Interventions

Transcatheter mitral valve repair

Transcatheter mitral valve repair performed using the MitraClip device

Guideline-directed medical therapy

Standard medical therapy for heart failure as recommended by HF guidelines

Primary outcome measure

  • Left ventricular diastolic remodelling [ Time Frame: 12 months ]
  • Functional capacity as measured by 6 minute walk test [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Anita W Asgar, MD

5143763330anita.asgar@umontreal.ca

Locations

Montreal Heart Institute

Recruiting

Montréal, Quebec, Canada, H1T1C8

Contacts

Anita W Asgar, MD

5143763330anita.asgar@umontreal.ca

More Information

Sponsor

Montreal Heart Institute

Last update posted

Aug 14, 2019

Last verified

Oct, 2018

Keywords

  • mitral regurgitation
  • transcatheter mitral valve repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal Heart Institute on 2019-08-14.