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

Completed

• Conditions: Mitral Regurgitation

• Registration Number: NCT03592043
• Lead Sponsor: Population Health Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Study Start: 2019-01-01
• Primary Completion: 2021-02-27
• Study Completion: 2021-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1191

Inclusion Criteria

• Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mitral Regurgitation (MR) severity	12 months

Secondary Outcome Measures

Name	Time	Method
Hospitalization for Heart Failure	12 months
All-cause mortality	12 months

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada