NCT05678868

Brief Summary

This is a prospective Quality Improvement (QI) study using the Model for Improvement framework. The objective of this study is to implement a structured, comprehensive, innovative, and sustainable approach to the management of patients with advanced mitral valve (MV) disease and heart failure (HF) in Southeastern Ontario and to improve healthcare delivery, patient care, and patient outcomes in the context of structural surgical and percutaneous MV interventions. This will be achieved through the strategic implementation, promotion, and evaluation of: i.The first local Southeastern Ontario Structural Mitral Valve Clinic using an Interdisciplinary heart team (IHT) at the Kingston Health Sciences Centre (KHSC) and its integration with the KHSC's existing Heart Failure Clinic; ii.The first provincial Structural Mitral Valve Clinic electronic referral service on the Ontario electronic services platform; and iii.The promotion of the above through targeted KT (Knowledge Transfer) outreach activities. Patients for this study will be recruited through medical referral within the south eastern Ontario, Canada region.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

September 7, 2022

Last Update Submit

December 22, 2022

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (3)

  • Wait time 1

    The time between date referral made and date acknowledged by cardiologist.

    At week three following study entry.

  • Wait time 2

    The time from acceptance for a procedure to time of pre-procedure imaging.

    At week sixteen following study entry.

  • Wait time 3

    The time from acceptance for a procedure to time of procedure.

    At week sixteen following study entry.

Secondary Outcomes (4)

  • Morbidity 1

    At 30 days post procedure.

  • Morbidity 2

    At one year post procedure.

  • Mortality 1

    At 30 days post procedure.

  • Mortality 2

    At one year post procedure.

Other Outcomes (7)

  • Electronic referral patient experience survey

    At day one (study entry).

  • Electronic referral usage - eReferrals answered

    At day one (study entry).

  • Electronic referral usage - response time

    At day one (study entry).

  • +4 more other outcomes

Interventions

MitraClip procedurePROCEDURE

MitraClip is surgical procedure to repair the mitral valve in your heart. During the procedure, the doctor will access the mitral valve using a thin tube (called a catheter) that is guided through a vein in your leg to reach your heart. A small implanted clip is attached to the mitral valve to reduce the leaking across the valve and to reduce symptoms and stress on the heart.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary and secondary moderate to severe MR with heart failure (HF) (preserved or reduced ejection fraction with New York Heart Association (NYHA) Class \>II), who have had at least one previous hospitalization for HF, require specialist advisement.

You may qualify if:

  • All adults (≥18 years of age) patients with primary and secondary moderate to severe MR with HF (preserved or reduced ejection fraction with New York Heart Association (NYHA) Class \>II), who have had at least one previous hospitalization for HR, require specialist advisement, and have provided signed informed consent.

You may not qualify if:

  • Those who are not eligible for either an MV surgical intervention or a TMVI procedure.
  • Females of childbearing age who are not willing or unable to use a reliable method of birth control.
  • Inpatient referrals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Brigita Zile, RN, CCRP

CONTACT

613-549-6666bvz@queensu.ca

Wael Abuzeid, MD

CONTACT

613-548-1383wael.abuzeid@queensu.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, Interventional Cardiologist, Assistant Professor, Department of Medicine

Study Record Dates

First Submitted

September 7, 2022

First Posted

January 10, 2023

Study Start

February 1, 2022

Primary Completion

January 31, 2024

Study Completion

January 31, 2025

Last Updated

January 10, 2023

Record last verified: 2022-12

Locations

CA(1)