Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

NCT ID: NCT05936125

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-08-01

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.

Conditions

Valvular Heart Disease; Tricuspid Valve Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with tricuspid valve regurgitation undergoing open heart surgery

Patients undergoing open heart surgery (for any reason) with concomitant tricuspid valve regurgitation

Group Type: EXPERIMENTAL

Annuloplasty Using Flexible Band

Intervention Type: OTHER

Tricuspid valve annuloplasty using a flexible band; (Polyethylene terephthalate band): (Dacron band)

Interventions

Annuloplasty Using Flexible Band

Tricuspid valve annuloplasty using a flexible band; (Polyethylene terephthalate band): (Dacron band)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Sayed

M.D. Mahmoud Kamel Mohamed Sayed

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut Hospital University

Asyut, , Egypt

Countries

Egypt

Facility Contacts

Mahmoud S [mahsayed]

Role: primary

Other Identifiers

282

Identifier Type: -

Identifier Source: org_study_id