MitraClip for Ventricular Remodeling, Left

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ventricular Remodeling, Left+3 More
MitraClip - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial found that the MitraClip was more effective than medical therapy in reducing cardiovascular morbidity and functional capacity.

Eligible Conditions
  • Ventricular Remodeling, Left

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 24 months

12 months
Change in Mitral Regurgitation Severity at 12 Months
Change in Quality of Life Assessment
24 months
Change In Mitral Regurgitation
Change in Mitral Regurgitation Severity at 24 Months

Trial Safety

Trial Design

2 Treatment Groups

Medical Therapy
1 of 2
MitraClip
1 of 2

Active Control

Experimental Treatment

224 Total Participants · 2 Treatment Groups

Primary Treatment: MitraClip · No Placebo Group · N/A

MitraClipExperimental Group · 2 Interventions: MitraClip, Medical Therapy · Intervention Types: Device, Drug
Medical TherapyActiveComparator Group · 2 Interventions: MitraClip, Medical Therapy · Intervention Types: Device, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MitraClip
2017
N/A
~2040
Medical Therapy
2015
N/A
~3100

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Montreal Heart InstituteLead Sponsor
113 Previous Clinical Trials
63,820 Total Patients Enrolled
Abbott Medical DevicesIndustry Sponsor
599 Previous Clinical Trials
363,162 Total Patients Enrolled
Andreas Orfanos, MDStudy DirectorMontreal Health Innovations Coordinating Centre
2 Previous Clinical Trials
6,925 Total Patients Enrolled
Jean Rouleau, MDPrincipal InvestigatorMontreal Heart Institute
1 Previous Clinical Trials
150 Total Patients Enrolled
Anique Ducharme, MDPrincipal InvestigatorMontreal Heart Institute
1 Previous Clinical Trials
174 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female at least 18 years of age.
You have moderate to severe functional mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology as determined by TTE, and confirmed by the ECL.
NT-proBNP > 800 pg/mL in patients with sinus rhythm.
Treatment and compliance with medical therapy for heart failure for at least 30 days.
You are able to walk a distance of 6 minutes without substantial physical limitations and without use of a walker or wheelchair and without use of a wheelchair.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.