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

August 31, 2021 updated by: Population Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who have undergone percutaneous mitral valve repair with the MitraClip Clip Delivery System in Canada.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MitraClip
All patients who have undergone percutaneous mitral valve repair with the MitraClip system in Canada
Device: MitraClip
Transcatheter Mitral Valve Repair with MitraClip
Other Names:
  • MitraClip Clip Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mitral Regurgitation (MR) severity
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 12 months
12 months
Hospitalization for Heart Failure
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Shamir Mehta, MD MSc FRCPC, Population Health Research Institute; McMaster University
  • Principal Investigator: Neil Fam, MD MSc FRCPC, St. Michael's Hospital, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

February 27, 2021

Study Completion (ACTUAL)

July 1, 2021

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (ACTUAL)

July 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREMISE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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