Prospective Multicenter Registry of Patients With Mitral Stenosis Undergoing Percutaneous Mitral Balloon Commissurotomy

Recruiting

• Conditions: Mitral Stenosis

• Registration Number: NCT07175532
• Lead Sponsor: Asan Medical Center

Brief Summary

The goal of this observational study is to learn about the clinical outcomes after percutaneous mitral balloon commissurotomy (PMBC) for patients with mitral stenosis (MS) using nation-wide multicenter prospective registry including tertiary-referral hospitals in Korea.

The main question it aims to answer is:

What is the clinical outcomes after PMBC? Which method is appropriate to determine inflated Inoue balloon size?

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Related Adverse Events	From enrollment to 1 year after PMBC

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, South Korea