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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatic Heart Disease

Intervention / Treatment
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* Device: Percutaneous Balloon Mitral Valvulotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: significant mitral stenosis low Wilkins score (< 10) mitral regurgitation grade not more than 2 Exclusion Criteria: high Wilkins score (>10) unfavorable anatomy presence of left appendage thrombus non-conclusive periprocedural TEE imaging

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard Inoue balloon technique<br>Those randomized to the standard care will undergo the procedure using the contemporary Inoue balloon system (Toray Industries, Japan), which is available in 4 sizes: 24, 26, 28 and 30 mm. | Device: Percutaneous Balloon Mitral Valvulotomy<br>* Stenotic mitral valve will be dilated to open the commissures<br>|
| Active Comparator: wire assisted crossing<br>The procedure is performed on a similar fashion until atrial septal entry. Once the atrial wall is traversed, and the Mullins sheath is within the left atrium, the mitral valve is crossed with a flexible 0.032- or 0.035 in- 145 cm J-tipped wire. This step could be assisted by a steerable sheath. Once the mitral valve is crossed, the initial wire will be exchanged with a looped stiff wire (Safari or similar) to the left ventricle by use of a 5/6 f pigtail catheter. A commercially available balloon is used to perform the valvulotomy/commissurotomy procedure. Choice of balloon size is made following the formula: Balloon size = patient height (cm)/10 + 10. Fine tuning of the balloon size will be performed peri-operative based on transesophageal echo findings. Use of a separate stiff wire placed in the left atrium/pulmonary vein to ease passage through the atrial septum is left to the discretion of the operator based on the anatomical challenges faced during the procedure. | Device: Percutaneous Balloon Mitral Valvulotomy<br>* Stenotic mitral valve will be dilated to open the commissures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in procedure duration | procedure time in minutes | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure failure | failed procedure after lengthy attempt | day 1 |