Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy
- Conditions
- Rheumatic Heart Disease
- Registration Number
- NCT06150274
- Lead Sponsor
- Helse Stavanger HF
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- significant mitral stenosis
- low Wilkins score (< 10)
- mitral regurgitation grade not more than 2
- high Wilkins score (>10)
- unfavourable anatomy
- presence of left appendage thrombus
- non-conclusive periprocedural trans oesophageal echocardiography imaging
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction in procedure duration day 1 procedure time in minutes
- Secondary Outcome Measures
Name Time Method procedure failure day 1 failed procedure after lengthy attempt
Trial Locations
- Locations (1)
Tikur Anbessa Specialized Hospital
🇪🇹Addis Ababa, Addis Abeba, Ethiopia
Tikur Anbessa Specialized Hospital🇪🇹Addis Ababa, Addis Abeba, Ethiopia