ClinicalTrials.gg
Not yet recruitingNCT07831811TMRSM_RUpdated Oct 14, 2026

Echocardiographic Perspectives on Transient Mitral Regurgitation After Septal Myectomy

An observational study in Hypertrophic Cardiomyopathy, sponsored by University Health Network, Toronto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by University Health Network, Toronto · Observational

Updated Oct 14, 2026Eligibility revisedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hypertrophic Cardiomyopathy

Keywords

  • Septal Myectomy
  • Mitral Regurgitation
03

In context

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

This study's planned enrollment of 150 is below the median of 259 across 174 observational studies indexed under Cardiomyopathy, Hypertrophic.

Browse Cardiomyopathy, Hypertrophic studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (≥18 years)
  • Undergoing septal myectomy for HOCM
  • Availability of intraoperative post-cardiopulmonary bypass TEE images
  • Availability of predischarge TTE

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. ≥ 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).

    Time frame: From January 1, 2022 to December 31, 2025

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided — The investigators may decided to share in the future

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 21, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Jul 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
Revised
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    Eligibility Revised
    + 6 other changes: index terms, verification date, description, conditions, arm descriptions and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07831811
Responsible party
Marcus Salvatori (Staff Anesthesiologist, University Health Network, Toronto) — Principal investigator
First posted
Sep 21, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Marcus Salvatori, MD
Contact
marcus.salvatori@uhn.ca
416-340-5164
Nishanthi Liyanage
Contact
nishanthi.liyanage@uhn.ca
6478572526
Marcus Salvatori, MD
principal investigator · University Health Network/Toronto General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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