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

Rheumatic Heart Disease Clinical Trial

— CROSSVal  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06150274
• Other study ID #: 523036
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Helse Stavanger HF
• Contact: Nigussie Bogale, MD, PhD
• Phone: +4741309313
• Email: nigussie.bogale[@]lyse.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Heart Disease

Intervention

Device:
• Percutaneous Balloon Mitral Valvulotomy
Stenotic mitral valve will be dilated to open the commissures

Locations

Country	Name	City	State
Ethiopia	Tikur Anbessa Specialized Hospital	Addis Ababa	Addis Abeba

Sponsors (2)

Lead Sponsor	Collaborator
Helse Stavanger HF	Haukeland University Hospital

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mortality	short and long term survival	30 days
Other	mortality	short and long term survival	3 months
Other	Hospitalization for heart failure	hospitalization for worsening heart failure	2 year
Other	Procedure related neurological events	new neurological events	day 1
Other	Procedure related neurological events	new neurological events	30 days
Other	Vascular complications requiring intervention	transfusion requiring bleeding or vascular complication requiring percutaneous or surgical intervention	day 1
Other	new arrythmia	previously non existing arrythmia registered after intervention	day 1
Other	new bradyarrythmia	new bradyarrythmia requiring device intervention	day 1
Primary	Reduction in procedure duration	procedure time in minutes	day 1
Secondary	procedure failure	failed procedure after lengthy attempt	day 1