Structural Mitral Valve Project

Recruiting

• Conditions: Mitral Regurgitation

• Registration Number: NCT05678868
• Lead Sponsor: Queen's University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-09-07
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-22
• Last Update Submitted: 2022-12-22
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10
• Primary Completion: 2024-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wait time 2	At week sixteen following study entry.	The time from acceptance for a procedure to time of pre-procedure imaging.
Wait time 1	At week three following study entry.	The time between date referral made and date acknowledged by cardiologist.
Wait time 3	At week sixteen following study entry.	The time from acceptance for a procedure to time of procedure.

Secondary Outcome Measures

Name	Time	Method
Morbidity 2	At one year post procedure.	Morbidity = all cause hospitalization and heart failure hospitalization post procedure.
Mortality 1	At 30 days post procedure.	Mortality = all cause mortality
Mortality 2	At one year post procedure.	Mortality = all cause mortality
Morbidity 1	At 30 days post procedure.	Morbidity = all cause hospitalization and heart failure hospitalization post procedure.

Trial Locations

Locations (1)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada