Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05936125

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Valvular Heart Disease Tricuspid Valve Regurgitation	Other: Annuloplasty Using Flexible Band	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with tricuspid valve regurgitation undergoing open heart surgery Patients undergoing open heart surgery (for any reason) with concomitant tricuspid valve regurgitation	Other: Annuloplasty Using Flexible Band Tricuspid valve annuloplasty using a flexible band; (Polyethylene terephthalate band): (Dacron band)

Arm

Intervention/Treatment

Experimental: Patients with tricuspid valve regurgitation undergoing open heart surgery

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

Other: Annuloplasty Using Flexible Band

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

Outcome Measures

Primary Outcome Measures

Tricuspid valve regurgitation [1 year post operative]
Using Echocardiography to asset tricuspid valve regurgitation

Secondary Outcome Measures

Tricuspid Annular Plane Systolic Excursion (TAPSE) [1 year post operative]
Using Echocardiography to asset Tricuspid Annular Plane Systolic Excursion (TAPSE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Hospital University	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahmoud Sayed, M.D. Mahmoud Kamel Mohamed Sayed, Assiut University

ClinicalTrials.gov Identifier:

NCT05936125

Other Study ID Numbers:

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mahmoud Sayed, M.D. Mahmoud Kamel Mohamed Sayed, Assiut University

Tricuspid Valve

Tricuspid Valve Regurgitation

Tricuspid Valve Annuloplasty

Additional relevant MeSH terms:

Heart Diseases

Heart Valve Diseases

Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Jul 7, 2023