UnknownNot Applicable

Structural Mitral Valve Project

Canada30 participantsStarted 2022-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wait time 1

Timeframe: At week three following study entry.

Wait time 2

Timeframe: At week sixteen following study entry.

Wait time 3

Timeframe: At week sixteen following study entry.

Trial details

NCT IDNCT05678868

SponsorQueen's University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-31

Contact for this trial

Brigita Zile, RN, CCRP

613-549-6666 bvz@queensu.ca

View on ClinicalTrials.gov More Mitral Regurgitation trials