Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Not Applicable

Not yet recruiting

• Conditions: Valvular Heart Disease; Tricuspid Valve Regurgitation
• Interventions: Other: Annuloplasty Using Flexible Band

• Registration Number: NCT05936125
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-22
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-28
• Last Update Submitted: 2023-06-28
• Study First Posted: 2023-07-07
• Last Update Posted: 2023-07-07
• Study Start: 2023-08-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with tricuspid valve regurgitation undergoing open heart surgery	Annuloplasty Using Flexible Band	Patients undergoing open heart surgery (for any reason) with concomitant tricuspid valve regurgitation

Primary Outcome Measures

Name	Time	Method
Tricuspid valve regurgitation	1 year post operative	Using Echocardiography to asset tricuspid valve regurgitation

Secondary Outcome Measures

Name	Time	Method
Tricuspid Annular Plane Systolic Excursion (TAPSE)	1 year post operative	Using Echocardiography to asset Tricuspid Annular Plane Systolic Excursion (TAPSE)

Trial Locations

Locations (1)

Assiut Hospital University; 🇪🇬 Assiut, Egypt