Mitral RegurgitationNCT05678868
Structural Mitral Valve Project
An observational study of Mitral Regurgitation, run by Queen's University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- MitraClip procedure
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2022to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Brigita Zile, RN, CCRP, 613-549-6666 ext. 7109, bvz@queensu.ca
Wael Abuzeid, MD, 613-548-1381, wael.abuzeid@queensu.ca
About this study
Official title: 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:
Read more
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
- Being tested
- MitraClip procedure
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip procedureProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Wait time 1
The time between date referral made and date acknowledged by cardiologist.
Measured: At week three following study entry.
Wait time 2
The time from acceptance for a procedure to time of pre-procedure imaging.
Measured: At week sixteen following study entry.
Wait time 3
The time from acceptance for a procedure to time of procedure.
Measured: At week sixteen following study entry.
Secondary outcomes (4)
Morbidity 1
Morbidity = all cause hospitalization and heart failure hospitalization post procedure.
Measured: At 30 days post procedure.
Morbidity 2
Morbidity = all cause hospitalization and heart failure hospitalization post procedure.
Measured: At one year post procedure.
Mortality 1
Mortality = all cause mortality
Measured: At 30 days post procedure.
Mortality 2
Mortality = all cause mortality
Measured: At one year post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Feb 2022
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- AFP Innovation Fund
- Responsible party
- Principal investigator, Wael Abuzeid, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678868
- Sponsor's protocol ID
- Version Date January 25, 2022
- Status last verified
- Dec 2022
- First submitted
- 7 Sep 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Structural Mitral Valve Clinic for the Management of Patients With Heart Failure Refractory to Medical Therapy
- ClinicalTrials.gov ID
- NCT05678868
- Acronym / sponsor ID
- Version Date January 25, 2022
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- AFP Innovation Fund
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClip procedureMitraClip 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. | Procedure or surgery | – |
Primary outcome
Wait time 1
Time frame: At week three following study entry.
The time between date referral made and date acknowledged by cardiologist.
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 3
Time frame: At week sixteen following study entry.
The time from acceptance for a procedure to time of procedure.
4 secondary outcomes
Morbidity 1
Time frame: At 30 days post procedure.
Morbidity 2
Time frame: At one year post procedure.
Mortality 1
Time frame: At 30 days post procedure.
Mortality 2
Time frame: At one year post procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brigita Zile, RN, CCRP (613-549-6666 ext. 7109, bvz@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wait time 1 (time frame: At week three following study entry.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.