Hypertrophic CardiomyopathyTMRSM_RNCT07831811
Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy
An observational study of Hypertrophic Cardiomyopathy, run by University Health Network, Toronto.
Trial summary
Mitral regurgitation (MR) following septal myectomy for hypertrophic obstructive cardiomyopathy may persist despite relief of systolic anterior motion and left ventricular outflow tract obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will be enrolling all patients who are ≥18 years and underwent Septal Myectomy surgery between January 1, 2020 and December 31, 2025
Who may be able to join
- Adult patients (≥18 years)
- Undergoing septal myectomy for HOCM
- Availability of intraoperative post-cardiopulmonary bypass TEE images
- Availability of predischarge TTE
Who cannot join
- Concomitant primary mitral valve disease due to structural abnormalities, prior ischemic MR or previous MV intervention (repair or replacement)
- Inadequate echocardiographic image quality precluding MR assessment
- Patients without paired TEE and TTE studies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transient Mitral Regurgitation Following Septal Myectomy: A Retrospective Echocardiographic Study
Mitral regurgitation (MR) following septal myectomy for hypertrophic obstructive cardiomyopathy may persist despite relief of systolic anterior motion and left ventricular outflow tract obstruction. Clinical observations suggest that a subset of postoperative MR may be transient and related to posterior leaflet restriction rather than structural mitral valve abnormality.
The investigators will perform a retrospective single-centre cohort study of patients undergoing septal myectomy between 2022 and 2025. Intraoperative post-bypass transesophageal echocardiograms and predischarge transthoracic echocardiograms will be independently reviewed to assess MR severity and mechanism.
The investigators hypothesize that a substantial proportion of moderate-or-greater postoperative MR resolves before discharge, supporting a conservative approach to mitral valve intervention and improving intraoperative echocardiographic decision-making.
Read the detailed description
Hypertrophic obstructive cardiomyopathy (HOCM) is characterized by asymmetric septal hypertrophy and dynamic LVOT obstruction. Septal myectomy is the standard surgical therapy for symptomatic patients refractory to medical management.
Mitral regurgitation (MR) in HOCM is classically related to systolic anterior motion (SAM) of the anterior leaflet. Following myectomy, relief of LVOT obstruction typically reduces SAM-associated MR. However; intraoperative transesophageal echocardiography (TEE) frequently demonstrates persistent or new MR following separation from cardiopulmonary bypass.
Clinical observation suggests that a subset of this MR may be due to transient posterior leaflet restriction, potentially related to incomplete myocardial protection in hypertrophied myocardium. This may result in MR that resolves prior to discharge without requiring mitral valve intervention. Misinterpretation of this transient phenomenon may lead to unnecessary surgical procedures.
There is currently limited systematic evaluation of the mechanism and natural history of MR observed immediately following myectomy. This study aims to address this knowledge gap using retrospective echocardiographic review.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Septal Myectomy, Mitral Regurgitation
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent septal myectomy at Toronto General Hospital between 2022 and 2025 | The investigators will enroll into the study all patients who underwent septal myectomy at Toronto General Hospital between January 1, 2020 and December 31, 2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
≥ moderate MR on intraoperative post-bypass TEE that improves to ≤ mild MR on predischarge transthoracic echocardiography (TTE)
To determine the proportion of patients with ≥ moderate MR on intraoperative post-bypass TEE that improves to ≤ mild MR on predischarge transthoracic echocardiography (TTE).
Measured: From January 1, 2022 to December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Salvatori, University Health Network, Toronto
- Investigators
- Marcus Salvatori, MD, Principal investigator, University Health Network/Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831811
- Sponsor's protocol ID
- 26-5497
- Acronym
- TMRSM_R
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators may decided to share in the future