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

NCT ID: NCT03592043

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mitral Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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MitraClip

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

MitraClip

Intervention Type DEVICE

Transcatheter Mitral Valve Repair with MitraClip

Interventions

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MitraClip

Transcatheter Mitral Valve Repair with MitraClip

Intervention Type DEVICE

Other Intervention Names

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MitraClip Clip Delivery System

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shamir Mehta, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute; McMaster University

Neil Fam, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto

Locations

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Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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PREMISE

Identifier Type: -

Identifier Source: org_study_id

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