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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03592043

Acronym

PREMISE

Enrollment

1191

Registered

2018-07-19

Start date

2019-01-01

Completion date

2021-07-01

Last updated

2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Keywords

MitraClip, Degenerative Mitral Regurgitation

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.

Interventions

DEVICEMitraClip

Transcatheter Mitral Valve Repair with MitraClip

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame
Mitral Regurgitation (MR) severity	12 months

Secondary

Measure	Time frame
Hospitalization for Heart Failure	12 months
All-cause mortality	12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026