Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508544574996 Date of Registration: 05/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Repair vs Non-Repair in Tricuspid Regurgitation
Official scientific title Outcomes of Repair Vs Non-Repair of Moderate Functional Tricuspid Valve Regurgitation in Patients Undergoing Mitral Valve Replacement for Severe Stenotic Rheumatic Mitral Valve
Brief summary describing the background and objectives of the trial Background and objectives: The tricuspid valve (TV) has three leaflets connected to papillary muscles via chordae tendineae. It lacks a distinct annulus but anchors at the atrioventricular junction near key heart structures. Tricuspid regurgitation (TR) is the main reason for repair, though procedures are rare despite affecting 1.6 million in the U.S. Untreated TR worsens outcomes, especially in heart failure, prompting growing interest in isolated repair. We aimed to compare T.V progression after mitral valve replacement in patients with rheumatic mitral valve sever stenosis and mild to moderate T.V reguarge.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 09/01/2024
Actual trial start date 09/01/2024
Anticipated date of last follow up 01/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Repair Group Single intraoperative procedure Single session (duration of surgery, typically 3–5 hours). Mitral Valve Replacement (MVR) + Tricuspid Valve Repair (TVR) via DeVega Annuloplasty MVR: Mechanical or bioprosthetic valve replacement for severe rheumatic mitral stenosis. TVR: Suture annuloplasty (DeVega technique) using 2/0 Ethibond suture with Teflon pledgets to narrow the tricuspid annulus (sized to 31–33 mm). Performed under cardiopulmonary bypass via median sternotomy. 25
Control Group No repair group Single intraoperative procedure Single session (duration of surgery, typically 3–5 hours) Mitral Valve Replacement (MVR) Alone. MVR: Mechanical or bioprosthetic valve replacement for severe rheumatic mitral stenosis. No intervention on the tricuspid valve (despite moderate functional TR). 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Severe rheumatic mitral stenosis + moderate functional TR. Age ≥ 20 years. Planned MVR with LVEF ≥ 50%. No organic TV disease or concomitant surgeries. Organic tricuspid valve disease (congenital, traumatic, endocarditis, carcinoid) Tricuspid stenosis LVEF < 50% Need for concomitant cardiac procedures Redo operations Other: severe PH, non-rheumatic MV disease, active infection Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 66 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/01/2024 Ethics Committee AL Azhar University Assiut
Ethics Committee Address
Street address City Postal code Country
Faisal St, Assiut Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Tricuspid regurgitation progression - Method: Echocardiography (grade 0–3) 12 months post-surgery
Secondary Outcome Right ventricular function: TAPSE (mm) at 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiac Sohag Center Sohag St. Sohag, Egypt Sohag Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Dahi Sohag St, Sohag Sohag Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University Faisal St, Assiut Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Dahi Ahmeddahi9797@gmail.com 201018416100 Sohag St, Sohag
City Postal code Country Position/Affiliation
Sohag Egypt Resident of Cardiothoracic Surgery
Role Name Email Phone Street address
Public Enquiries Abdelkareem Elias kareemmgerem1235.el@azhar.edu.eg 201093959901 Faisal St, Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Assistant Professor of General Surgery
Role Name Email Phone Street address
Scientific Enquiries John Sedkey jon.sodky@med.svu.edu.eg 201220506092 Sohag St, Sohag
City Postal code Country Position/Affiliation
Sohag Egypt Consultant of Cardiothoracic Surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication. open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 05/08/2025 PACTR Admin 09 Jan 2024