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.

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

all collected IPD, all IPD that underlie results in a publication

November 2023 through december 2026

application must be submitted and signed electronically. The study team will asess the submitted proposals.