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Clinical Trials/NCT05936125
NCT05936125
Not Yet Recruiting
N/A

Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Assiut University1 site in 1 country20 target enrollmentAugust 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Valvular Heart Disease
Sponsor
Assiut University
Enrollment
20
Locations
1
Primary Endpoint
Tricuspid valve regurgitation
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
August 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Sayed

M.D. Mahmoud Kamel Mohamed Sayed

Assiut University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Tricuspid valve regurgitation

Time Frame: 1 year post operative

Using Echocardiography to asset tricuspid valve regurgitation

Secondary Outcomes

  • Tricuspid Annular Plane Systolic Excursion (TAPSE)(1 year post operative)

Study Sites (1)

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