Structural Mitral Valve Project

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05678868
• Other study ID #: Version Date January 25, 2022
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2022
• Source: Queen's University
• Contact: Brigita Zile, RN, CCRP
• Phone: 613-549-6666
• Email: bvz[@]queensu.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	AFP Innovation Fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	Electronic referral usage - eReferrals answered	Proportion (%) of eReferral answered	At day one (study entry).
Other	Electronic referral usage - response time	median specialist response interval time (days).	At day one (study entry).
Other	Electronic referral usage - inappropriate eReferrals	proportion (%) of inappropriate eReferrals.	At day one (study entry).
Other	Electronic referral usage - specialist time	median time (hours) spent by specialist on eReferral.	At day one (study entry).
Other	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.
Other	Cost comparison 2	Cost comparison between eReferral and traditional referrals based on number of missed clinic visits.	On the day prior to procedure.
Primary	Wait time 1	The time between date referral made and date acknowledged by cardiologist.	At week three following study entry.
Primary	Wait time 2	The time from acceptance for a procedure to time of pre-procedure imaging.	At week sixteen following study entry.
Primary	Wait time 3	The time from acceptance for a procedure to time of procedure.	At week sixteen following study entry.
Secondary	Morbidity 1	Morbidity = all cause hospitalization and heart failure hospitalization post procedure.	At 30 days post procedure.
Secondary	Morbidity 2	Morbidity = all cause hospitalization and heart failure hospitalization post procedure.	At one year post procedure.
Secondary	Mortality 1	Mortality = all cause mortality	At 30 days post procedure.
Secondary	Mortality 2	Mortality = all cause mortality	At one year post procedure.