Clinical trial NCT05678868: Structural Mitral Valve Project
Official title: Implementation of a Structural Mitral Valve Clinic for the Management of Patients With Heart Failure Refractory to Medical Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Regurgitation
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: AFP Innovation Fund
First posted: 2023-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Wait time 1
timeFrame: At week three following study entry.
measure: Wait time 2
timeFrame: At week sixteen following study entry.
measure: Wait time 3
timeFrame: At week sixteen following study entry.
Secondary outcomes:
measure: Morbidity 1
timeFrame: At 30 days post procedure.
measure: Morbidity 2
timeFrame: At one year post procedure.
measure: Mortality 1
timeFrame: At 30 days post procedure.
measure: Mortality 2
timeFrame: At one year post procedure.
Other outcomes:
measure: Electronic referral patient experience survey
timeFrame: At day one (study entry).
measure: Electronic referral usage - eReferrals answered
timeFrame: At day one (study entry).
measure: Electronic referral usage - response time
timeFrame: At day one (study entry).
measure: Electronic referral usage - inappropriate eReferrals
timeFrame: At day one (study entry).
measure: Electronic referral usage - specialist time
timeFrame: At day one (study entry).
measure: Cost comparison 1
timeFrame: At one day post procedure.
measure: Cost comparison 2
timeFrame: On the day prior to procedure.
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
References: