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

NCT ID: NCT06150274

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2024-06-03

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.

Conditions

Rheumatic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard Inoue balloon technique

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Balloon Mitral Valvulotomy

Intervention Type: DEVICE

Stenotic mitral valve will be dilated to open the commissures

wire assisted crossing

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.

Group Type: ACTIVE_COMPARATOR

Percutaneous Balloon Mitral Valvulotomy

Intervention Type: DEVICE

Stenotic mitral valve will be dilated to open the commissures

Interventions

Percutaneous Balloon Mitral Valvulotomy

Stenotic mitral valve will be dilated to open the commissures

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nigussie Bogale, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital, Bergen, Norway

Locations

Tikur Anbessa Specialized Hospital

Addis Ababa, Addis Abeba, Ethiopia

Countries

Ethiopia

Other Identifiers

523036

Identifier Type: -

Identifier Source: org_study_id