Registry of mitral stenosis patients treated with percutaneous mitral balloon commissurotomy
Prospective Multicenter Registry of Patients With Mitral Stenosis Undergoing Percutaneous Mitral Balloon Commissurotomy
See how people with mitral stenosis do after percutaneous mitral balloon commissurotomy (PMBC) and which method best determines the Inoue balloon size.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07175532 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter registry enrolling patients with mitral stenosis who undergo PMBC at tertiary referral hospitals in Korea. Investigators will collect baseline clinical data, procedural details, and follow-up outcomes to characterize short- and long-term results after PMBC. The registry will compare methods used to choose the Inoue balloon size and correlate sizing approaches with clinical and echocardiographic outcomes. Participation is observational and does not change clinical care beyond standard procedures and follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults with mitral stenosis who are scheduled for PMBC, can give informed consent, and do not have severe comorbidities that limit life expectancy to under one year.
Not a fit: Patients who cannot provide informed consent, have serious comorbid conditions limiting life expectancy, or have non-cardiac limitations (NYHA III–IV) are unlikely to gain benefit from participation.
Why it matters
Potential benefit: If successful, the registry could help clinicians choose the best balloon sizing method and improve outcomes after PMBC.
How similar studies have performed: PMBC outcomes and balloon sizing have been reported in prior single-center and registry reports, so the general approach is established though this multicenter Korean prospective registry aims to add broader, country-level data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with mitral stenosis undergoing PMBC Exclusion Criteria: * Patients who cannot understand this study due to mental illness * Serious comorbidity limiting life expectancy within 1 year * Limited activity (NYHA class III or IV) due to non-cardiac disease
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jong-Min Song
- Email: jmsong@amc.seoul.kr
- Phone: 82230103168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.