Structural Mitral Valve Project

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Procedure: MitraClip procedure

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Brigita Zile, RN, CCRP; Phone Number: 7109 613-549-6666; Email: bvz@queensu.ca
• Study Contact Backup: Name: Wael Abuzeid, MD; Phone Number: 613-548-1383; Email: wael.abuzeid@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre
      • Contact: Brigita Zile, RN, CCRP; Phone Number: 7109 613-549-6666; Email: bvz@queensu.ca
      • Contact: Wael Abuzeid, MD; Phone Number: 613-548-1381; Email: wael.abuzeid@queensu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electronic referral patient experience survey	A survey of patient experience and satisfaction with the electronic referral method. Comments: The survey will be developed by the study investigator and each patient experience related question will be answered using the following scale: Strongly agree ☐ Agree ☐ Neither agree or disagree ☐ Disagree ☐ Strongly disagree. ☐ NA	At day one (study entry).
Electronic referral usage - eReferrals answered	Proportion (%) of eReferral answered	At day one (study entry).
Electronic referral usage - response time	median specialist response interval time (days).	At day one (study entry).
Electronic referral usage - inappropriate eReferrals	proportion (%) of inappropriate eReferrals.	At day one (study entry).
Electronic referral usage - specialist time	median time (hours) spent by specialist on eReferral.	At day one (study entry).
Cost comparison 1	Cost comparison between eReferral and traditional referrals based on number of baseline (pre-procedural) lab tests and investigations.	At one day post procedure.
Cost comparison 2	Cost comparison between eReferral and traditional referrals based on number of missed clinic visits.	On the day prior to procedure.

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: AFP Innovation Fund

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: Version Date January 25, 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No