NCT03705312

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 22, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 14, 2019

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

August 4, 2018

Last Update Submit

August 12, 2019

Conditions

Mitral RegurgitationHeart FailureMitral Valve Regurgitation Due to Cardiomyopathy (Disorder)

Keywords

mitral regurgitationtranscatheter mitral valve repair

Outcome Measures

Primary Outcomes (2)

  • Left ventricular diastolic remodelling

    Change in indexed left ventricular diastolic volume (LVEDV)

    12 months

  • Functional capacity as measured by 6 minute walk test

    Change in distance walked on six-minute walk test

    12 months

Secondary Outcomes (3)

  • Mitral regurgitation Severity (RV)

    12 months

  • Mitral regurgitation Severity (EROA)

    12 months

  • Quality of Life Measurement

    12 months

Study Arms (2)

Guideline-directed medical therapy

PLACEBO COMPARATOR

Standard guideline-directed medical treatment for heart failure

Other: Guideline-directed medical therapy

Transcatheter Mitral valve repair

EXPERIMENTAL

MitraClip treatment

Device: Transcatheter mitral valve repair

Interventions

Transcatheter mitral valve repairDEVICE

Transcatheter mitral valve repair performed using the MitraClip device

Also known as: MitraClip
Transcatheter Mitral valve repair
Guideline-directed medical therapyOTHER

Standard medical therapy for heart failure as recommended by HF guidelines

Guideline-directed medical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate functional mitral regurgitation (2+, 2-3+)
  • Left ventricular ejection fraction \>20%
  • LVEDV 75-110 ml/m2
  • Symptomatic heart failure (NYHA Class II-IV)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

RECRUITING

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart Failure

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Anita W Asgar, MD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

  • Anique Ducharme, MD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

  • Jean L Rouleau, MD

    Montreal Heart Institute

    STUDY CHAIR

Central Study Contacts

Anita W Asgar, MD

CONTACT

5143763330anita.asgar@umontreal.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized 1:1 to medical treatment or intervention with the MitraClip device
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2018

First Posted

October 15, 2018

Study Start

February 22, 2019

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

August 14, 2019

Record last verified: 2018-10

Locations

CA(1)