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Clinical Trials/NCT05936125
NCT05936125Not yet recruitingNot Applicable

Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Assiut University2 sites in 1 country20 target enrollmentStarted: August 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
20
Locations
2
Primary Endpoint
Tricuspid valve regurgitation

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Sayed

M.D. Mahmoud Kamel Mohamed Sayed

Assiut University

Study Sites (2)

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