Late Clinical Outcomes of Percutaneous Mitral Commissurotomy in Patients With Mitral Stenosis

NCT04112108 | Completed DMC

• 1 other identifier: 97-55318
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

In this retrospective cohort study, out of 220 patients who had undergone successful PTMC between 2006 and 2018, the clinical course of 186 patients could be successfully followed. Peri-procedural clinical and echocardiographic data were collected for these patients. Cardiac-related death, undergoing a second PTMC or mitral valve replacement (MVR) were considered adverse cardiac events in follow-up for the purpose of this study. Patients with no history of these events were contacted and asked to undergo echocardiographic imaging, in order to assess the prevalence of mitral valve restenosis, defined as mitral valve area (MVA) \< 1.5 cm2 and loss of ≥50% of initial area gain

Conditions

Mitral Valve Stenosis

Keywords

percutaneous mitral commissurotomy; follow up

Outcome Measures

Primary Outcomes (1)

• mitral stenosis

  mitral valve area in echocardiographic evaluation\<1.5 cm2

  5.6 years

Secondary Outcomes (1)

• functional class

  5.6 years

Study Arms (1)

mitral stenosis post percutaneous mitral commissurotomy(PTMC)

successful PTMC after follow up

Procedure: PTMC

Interventions

PTMC PROCEDURE

percutaneous mitral ballooning with Inoue balloon

Also known as: mitral ballooning

mitral stenosis post percutaneous mitral commissurotomy(PTMC)

Eligibility Criteria

• Age: 35 Years - 52 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

: In this retrospective cohort study, out of 220 patients who had undergone successful PTMC between 2006 and 2018, the clinical course of 186 patients could be successfully followed. Peri-procedural clinical and echocardiographic data were collected for these patients. Cardiac-related death, undergoing a second PTMC or mitral valve replacement (MVR) were considered adverse cardiac events in follow-up for the purpose of this study. Patients with no history of these events were contacted and asked to undergo echocardiographic imaging, in order to assess the prevalence of mitral valve restenosis, defined as mitral valve area (MVA) \< 1.5 cm2 and loss of ≥50% of initial area gain

You may qualify if:

• each patient with mitral stenosis undergone successful PTMC

You may not qualify if:

• patient refuse to took part
• inability to follow patient

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Baqiyatallah Medical Sciences University: collaborator

Study Sites (1)

Education Developmen Center

Shiraz, Fars, 55318, Iran

Location

Related Publications (1)

• Dadjo Y, Moshkani Farahani M, Nowshad R, Sadeghi Ghahrodi M, Moaref A, Kojuri J. Mid-term (up to 12 years) clinical and echocardiographic outcomes of percutaneous transvenous mitral commissurotomy in patients with rheumatic mitral stenosis. BMC Cardiovasc Disord. 2021 Jul 28;21(1):355. doi: 10.1186/s12872-021-02175-3.

  PMID: 34320949 DERIVED

MeSH Terms

Conditions

Mitral Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: March 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 20, 2018
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)