Structural Mitral Valve Project

Queen's University

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Procedure: MitraClip procedure

Study type: Observational

Funder types: Other

Identifiers

NCT05678868

Version Date January 25, 2022

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.