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

Population Health Research Institute (PHRI)

Status: Completed

Conditions: Mitral Regurgitation

Treatments: Device: MitraClip

Study type: Observational

Funder types: Other

Identifiers

NCT03592043

PREMISE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,191 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

1,191 participants in 1 patient group

MitraClip

Description:

All patients who have undergone percutaneous mitral valve repair with the MitraClip system in Canada

Treatment:

Device: MitraClip