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

NCT ID: NCT07175532

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2031-12-31

Brief Summary

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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

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Conditions

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Mitral Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong-Min Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong-Min Song

Role: CONTACT

82230103168

Facility Contacts

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Jong-Min Song

Role: primary

82230103168

Other Identifiers

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2025-0396

Identifier Type: -

Identifier Source: org_study_id

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