NCT06150274

Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy

Simplifying Percutaneous Balloon Mitral Valvulotomy (PBMV) to Reduce the Burden of Mitral Stenosis in Sub-Saharan Africa.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomised study is comparison of wire assisted balloon mitral valvulotomy to standard Inoue balloon technique on patients with rheumatic mitral stenosis. The main question it aims to answer is whether procedure time is reduced using the wire assisted method. Participants will be randomized to one of the two methods.

Detailed description

Background: Rheumatic valvular disease, a chronic sequela of acute rheumatic fever, is a leading cause of cardiovascular mortality in developing countries. The available options of management include surgical treatment and balloon valvulotomy. Among various forms of rheumatic valvular lesions, severe mitral stenosis with favorable morphology can be successfully treated by balloon valvulotomy. Methods: The study is a randomized controlled trial with intervention in both arms. The objective of this study is to compare procedural time as a primary end point.

Conditions

• Rheumatic Heart Disease

Interventions

Type	Name	Description
DEVICE	Percutaneous Balloon Mitral Valvulotomy	Stenotic mitral valve will be dilated to open the commissures

Timeline

• Start date: 2024-05-24
• Primary completion: 2024-05-31
• Completion: 2024-06-03
• First posted: 2023-11-29
• Last updated: 2024-06-20

Locations

1 site across 1 country: Ethiopia

Regulatory

• FDA-regulated device study