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NCT03592043 Clinical Trial

A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy

Mitral Regurgitation Clinical Trial

— PREMISE  

Official title:
A Retrospective Multicenter Canadian Registry of Patients With Mitral Regurgitation Undergoing Percutaneous Mitral Valve Repair With MitraClip

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03592043
Other study ID # PREMISE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date July 1, 2021

Study information
Verified date August 2021
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The PREMISE Registry is a retrospective, observational study that will evaluate the efficacy and safety of the MitraClip in real-world Canadian practice. It will include all patients who have undergone MitraClip implantation in Canada to date.

Description:

In addition to evaluating efficacy and safety, PREMISE will include a description of patient demographics, etiology of mitral regurgitation, co-morbidities, medication use and functional class. It will also compare re-hospitalization for heart failure 12 months prior and 12 months after the procedure.

Recruitment information / eligibility
Status Completed
Enrollment 1191
Est. completion date July 1, 2021
Est. primary completion date February 27, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MitraClip
Transcatheter Mitral Valve Repair with MitraClip

Locations
Country Name City State
Canada Hamilton General Hospital Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mitral Regurgitation (MR) severity 12 months
Secondary Hospitalization for Heart Failure 12 months
Secondary All-cause mortality 12 months
See also
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Not yet recruiting NCT06167213 - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral N/A
Not yet recruiting NCT06465745 - AltaValve Pivotal Trial N/A
Withdrawn NCT05040451 - Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Withdrawn NCT03714412 - Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System N/A
Recruiting NCT02592889 - (MitraClip in Non-Responders to Cardiac Resynchronization Therapy) Phase 4
Completed NCT02355418 - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Completed NCT01841554 - Cardioband With Transfemoral Delivery System N/A
Not yet recruiting NCT01431222 - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery Phase 4
Not yet recruiting NCT03870516 - Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery N/A
Active, not recruiting NCT03230747 - SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation N/A
Enrolling by invitation NCT04031274 - Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
Completed NCT05836532 - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Completed NCT05850026 - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Completed NCT05836480 - Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Recruiting NCT03975998 - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2