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Clinical Trials/NCT05678868
NCT05678868
Recruiting
Not Applicable

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

Queen's University1 site in 1 country30 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Queen's University
Enrollment
30
Locations
1
Primary Endpoint
Wait time 2
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
January 31, 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wael Abuzeid

MD, MSc, Interventional Cardiologist, Assistant Professor, Department of Medicine

Queen's University

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.

Outcomes

Primary Outcomes

Wait time 2

Time Frame: At week sixteen following study entry.

The time from acceptance for a procedure to time of pre-procedure imaging.

Wait time 1

Time Frame: At week three following study entry.

The time between date referral made and date acknowledged by cardiologist.

Wait time 3

Time Frame: At week sixteen following study entry.

The time from acceptance for a procedure to time of procedure.

Secondary Outcomes

  • Morbidity 2(At one year post procedure.)
  • Mortality 1(At 30 days post procedure.)
  • Mortality 2(At one year post procedure.)
  • Morbidity 1(At 30 days post procedure.)

Study Sites (1)

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