Structural Mitral Valve Project

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of a Structural Mitral Valve Clinic for the Management of Patients With Heart Failure Refractory to Medical Therapy

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Procedure: MitraClip procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MitraClip procedure|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity 1 | Morbidity = all cause hospitalization and heart failure hospitalization post procedure. | At 30 days post procedure. | 
| Morbidity 2 | Morbidity = all cause hospitalization and heart failure hospitalization post procedure. | At one year post procedure. | 
| Mortality 1 | Mortality = all cause mortality | At 30 days post procedure. | 
| Mortality 2 | Mortality = all cause mortality | At one year post procedure. |