Actively Recruiting
Prospective Multicenter Registry of Patients With Mitral Stenosis Undergoing Percutaneous Mitral Balloon Commissurotomy
Led by Asan Medical Center · Updated on 2025-09-16
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to learn about the clinical outcomes after percutaneous mitral balloon commissurotomy (PMBC) for patients with mitral stenosis (MS). The study uses a nationwide multicenter prospective registry that includes tertiary-referral hospitals in Korea. It aims to answer questions about the clinical outcomes after PMBC and which method is best to determine the inflated Inoue balloon size. This study observes patients with mitral stenosis who are undergoing PMBC without assigning treatments or interventions. It collects information from multiple hospitals to gather comprehensive data on this procedure. Participants are followed to track treatment-related adverse events from enrollment up to one year after PMBC. Participants will be involved in regular monitoring for up to one year after the procedure to assess any treatment-related side effects. Researchers will review clinical data and adverse events during this time. The study focuses on collecting information about safety and outcomes related to PMBC. Total participation duration depends on enrollment and follow-up through one year after treatment.
CONDITIONS
Brief Title
Prospective Multicenter Registry of Patients With Mitral Stenosis Undergoing Percutaneous Mitral Balloon Commissurotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with mitral stenosis undergoing PMBC
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the procedure
Participants undergo percutaneous mitral balloon commissurotomy as part of routine care and are observed.
1 visit (in-person)
Duration - Up to 1 year after the procedure
Participants are monitored for treatment-related adverse events and health outcomes after the procedure.
Periodic follow-up visits up to 1 year
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
J
Jong-Min Song
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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