A Pan-Canadian, Retrospective Evaluation of MitraClip Safety and Efficacy
Completed
- Conditions
- Mitral Regurgitation
- Interventions
- Device: MitraClip
- 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.
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
- Arm && Interventions
Group Intervention Description MitraClip MitraClip All patients who have undergone percutaneous mitral valve repair with the MitraClip system in Canada
- 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