Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

NCT05936125 | Unknown

• 1 other identifier: 282
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Tricuspid Valve; Tricuspid Valve Regurgitation; Tricuspid Valve Annuloplasty

Outcome Measures

Primary Outcomes (1)

• Tricuspid valve regurgitation

  Using Echocardiography to asset tricuspid valve regurgitation

  1 year post operative

Secondary Outcomes (1)

• Tricuspid Annular Plane Systolic Excursion (TAPSE)

  1 year post operative

Study Arms (1)

Patients with tricuspid valve regurgitation undergoing open heart surgery

EXPERIMENTAL

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

Other: Annuloplasty Using Flexible Band

Interventions

Annuloplasty Using Flexible Band OTHER

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

Patients with tricuspid valve regurgitation undergoing open heart surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presented at Assiut University Hospital with tricuspid valve regurgitation

You may not qualify if:

• Age less than 18 years old.
• Tricuspid valve stenosis.
• Organic tricuspid valve disease.
• Infective endocarditis on tricuspid valve.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Hospital University

Asyut, Egypt

Location

MeSH Terms

Conditions

Heart Valve Diseases; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Mahmoud Kamel Mohamed Sayed

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: July 7, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-06

Locations

EG (1)