Simplifying Percutaneous Balloon Mitral Valvulotomy (PBMV) to Reduce the Burden of Mitral Stenosis in Sub-Saharan Africa.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Helse Stavanger HF
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Reduction in procedure duration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •significant mitral stenosis
- •low Wilkins score (< 10)
- •mitral regurgitation grade not more than 2
Exclusion Criteria
- •high Wilkins score (>10)
- •unfavourable anatomy
- •presence of left appendage thrombus
- •non-conclusive periprocedural trans oesophageal echocardiography imaging
Outcomes
Primary Outcomes
Reduction in procedure duration
Time Frame: day 1
procedure time in minutes
Secondary Outcomes
- procedure failure(day 1)