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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Stenotic mitral valve will be dilated to open the commissures
Tikur Anbessa Specialized Hospital
Addis Ababa, Addis Abeba, Ethiopia
Reduction in procedure duration
procedure time in minutes
Time frame: day 1
procedure failure
failed procedure after lengthy attempt
Time frame: day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.