Rheumatic Heart Disease
Conditions
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.
Interventions
DEVICEPercutaneous Balloon Mitral Valvulotomy
Stenotic mitral valve will be dilated to open the commissures
Sponsors
Haukeland University Hospital
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in procedure duration | day 1 | procedure time in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure failure | day 1 | failed procedure after lengthy attempt |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedure related neurological events | day 1 | new neurological events |
| Vascular complications requiring intervention | day 1 | transfusion requiring bleeding or vascular complication requiring percutaneous or surgical intervention |
| mortality | 30 days | short and long term survival |
| new bradyarrythmia | day 1 | new bradyarrythmia requiring device intervention |
| new arrythmia | day 1 | previously non existing arrythmia registered after intervention |
| Hospitalization for heart failure | 2 year | hospitalization for worsening heart failure |
Countries
Ethiopia
Outcome results
None listed