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

Not Applicable

Completed

• Conditions: Rheumatic Heart Disease
• Interventions: Device: Percutaneous Balloon Mitral Valvulotomy

• 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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-29
• Study Start: 2024-05-24
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-03
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard Inoue balloon technique	Percutaneous Balloon Mitral Valvulotomy	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.
wire assisted crossing	Percutaneous Balloon Mitral Valvulotomy	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.

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