NCT03592043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,191

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

July 9, 2018

Last Update Submit

August 31, 2021

Conditions

Mitral Regurgitation

Keywords

MitraClipDegenerative Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Mitral Regurgitation (MR) severity

    12 months

Secondary Outcomes (2)

  • Hospitalization for Heart Failure

    12 months

  • All-cause mortality

    12 months

Study Arms (1)

MitraClip

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

Device: MitraClip

Interventions

MitraClipDEVICE

Transcatheter Mitral Valve Repair with MitraClip

Also known as: MitraClip Clip Delivery System
MitraClip

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

July 19, 2018

Study Start

January 1, 2019

Primary Completion

February 27, 2021

Study Completion

July 1, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

CA(1)