Recruiting

Observational Study

Sponsor:

Queen's University

Code:

NCT05678868

Conditions

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MitraClip procedure

Study Details

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.

Conditions

Mitral Regurgitation

Study ID

NCT05678868

Start date

Feb 1, 2022

Status verified date

Dec, 2022

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Jan 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Wait time 1 [ Time Frame: At week three following study entry. ]
  • Wait time 2 [ Time Frame: At week sixteen following study entry. ]
  • Wait time 3 [ Time Frame: At week sixteen following study entry. ]

Central Contacts and Locations

Central contacts

Brigita Zile, RN, CCRP

613-549-6666bvz@queensu.ca

Wael Abuzeid, MD

613-548-1383wael.abuzeid@queensu.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Brigita Zile, RN, CCRP

613-549-6666bvz@queensu.ca

Wael Abuzeid, MD

613-548-1381wael.abuzeid@queensu.ca

More Information

Sponsor

Queen's University

Last update posted

Jan 10, 2023

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2023-01-10.