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Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Primary Purpose

Valvular Heart Disease, Tricuspid Valve Regurgitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Annuloplasty Using Flexible Band
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Valvular Heart Disease focused on measuring Tricuspid Valve, Tricuspid Valve Regurgitation, Tricuspid Valve Annuloplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Assiut Hospital University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with tricuspid valve regurgitation undergoing open heart surgery

Arm Description

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

Outcomes

Primary Outcome Measures

Tricuspid valve regurgitation
Using Echocardiography to asset tricuspid valve regurgitation

Secondary Outcome Measures

Tricuspid Annular Plane Systolic Excursion (TAPSE)
Using Echocardiography to asset Tricuspid Annular Plane Systolic Excursion (TAPSE)

Full Information

First Posted
April 22, 2023
Last Updated
June 28, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05936125
Brief Title
Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band
Official Title
Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease, Tricuspid Valve Regurgitation
Keywords
Tricuspid Valve, Tricuspid Valve Regurgitation, Tricuspid Valve Annuloplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with tricuspid valve regurgitation undergoing open heart surgery
Arm Type
Experimental
Arm Description
Patients undergoing open heart surgery (for any reason) with concomitant tricuspid valve regurgitation
Intervention Type
Other
Intervention Name(s)
Annuloplasty Using Flexible Band
Intervention Description
Tricuspid valve annuloplasty using a flexible band; (Polyethylene terephthalate band): (Dacron band)
Primary Outcome Measure Information:
Title
Tricuspid valve regurgitation
Description
Using Echocardiography to asset tricuspid valve regurgitation
Time Frame
1 year post operative
Secondary Outcome Measure Information:
Title
Tricuspid Annular Plane Systolic Excursion (TAPSE)
Description
Using Echocardiography to asset Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time Frame
1 year post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Assiut Hospital University
City
Assiut
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud S [mahsayed]

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

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