A Pan-Canadian, Retrospective Evaluation of MitraClip Saf... | NCT03592043

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

NCT03592043

Sponsor

Population Health Research Institute

Status

Completed

Last Update Posted

Sep 2, 2021Actual

Enrollment

1,191Actual

Phase

Not provided

Conditions

Mitral Regurgitation

Interventions

MitraClip

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Feb 27, 2021Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Jul 9, 2018

First Submission Date that Met QC Criteria

Jul 9, 2018

First Posted Date

Jul 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2021

Last Update Posted Date

Sep 2, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MitraClip		All patients who have undergone percutaneous mitral valve repair with the MitraClip system in Canada	Device: MitraClip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MitraClip	Device	Transcatheter Mitral Valve Repair with MitraClip	MitraClip

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mitral Regurgitation (MR) severity		12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton General Hospital		Hamilton	Ontario	L8L2X2	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided