Valvular Heart Disease Clinical Trial
Official title:
Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band
| Verified date | June 2023 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Functional tricuspid regurgitation (FTR) remains a common finding in patients with left-sided valvular heart diseases especially mitral valve regurgitation or stenosis. It is mainly caused by dilatation and flattening of the tricuspid valve (TV) annulus as a result of right ventricular (RV) enlargement and is inevitably affected by the RV function. Multiple studies support the better outcome of using rigid ring annuloplasty over suture repair for treating FTR in concern with the durability and freedom from residual regurgitation. These studies refer the superiority of rigid ring annloplasty to the three-dimensional configuration achieved by such rings which matches the normal tricuspid annulus and, at the same time, to the rigid support of the annulus. On the other hand, other studies support the use of flexible prosthetic bands like Dacron or polytetrafluroethilin (PTFE), especially over suture techniques, due to their easy applicability and availability with good postoperative results. Therefore, suture annyloplasty became nowadays less convenient for FTR repair since both flexible bands and rigid rings appeared to offer good midterm outcomes in recent meta-analysis studies. However, the ideal annuloplasty method for repairing FTR is still debatable between the three-dimensional (3D) rigid rings versus flexible prosthetic bands. In this retrospective comparative study, we share our experience with flexible fashioned bands in FTR.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | August 1, 2024 |
| Est. primary completion date | August 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - All patients presented at Assiut University Hospital with tricuspid valve regurgitation Exclusion Criteria: - Age less than 18 years old. - Tricuspid valve stenosis. - Organic tricuspid valve disease. - Infective endocarditis on tricuspid valve. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Assiut Hospital University | Assiut |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tricuspid valve regurgitation | Using Echocardiography to asset tricuspid valve regurgitation | 1 year post operative | |
| Secondary | Tricuspid Annular Plane Systolic Excursion (TAPSE) | Using Echocardiography to asset Tricuspid Annular Plane Systolic Excursion (TAPSE) | 1 year post operative |
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