NCT07175532

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
May 2025Dec 2031

Study Start

First participant enrolled

May 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

6.7 years

First QC Date

September 15, 2025

Last Update Submit

September 15, 2025

Conditions

Mitral Stenosis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Treatment-Related Adverse Events

    From enrollment to 1 year after PMBC

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with mitral stenosis undergoing PMBC

You may qualify if:

  • Patients with mitral stenosis undergoing PMBC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Jong-Min Song

CONTACT

82230103168jmsong@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2025

First Posted

September 16, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

September 16, 2025

Record last verified: 2025-09

Locations

KR(1)