Status:
COMPLETED
Comparison of Wire Assisted Percutaneous Balloon Mitral Valvulotomy With Standard Inoue Balloon Valvulotomy
Lead Sponsor:
Helse Stavanger HF
Collaborating Sponsors:
Haukeland University Hospital
Conditions:
Rheumatic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- significant mitral stenosis
- low Wilkins score (\< 10)
- mitral regurgitation grade not more than 2
Exclusion
- high Wilkins score (\>10)
- unfavourable anatomy
- presence of left appendage thrombus
- non-conclusive periprocedural trans oesophageal echocardiography imaging
Key Trial Info
Start Date :
May 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06150274
Start Date
May 24 2024
End Date
June 3 2024
Last Update
June 20 2024
Active Locations (1)
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1
Tikur Anbessa Specialized Hospital
Addis Ababa, Addis Abeba, Ethiopia, 2500