Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201707002387209 Date of Registration: 28/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title PRESERVATION OF THE ANNULO-PAPILLARY CONTINUITY DURING MITRAL VALVE REPLACEMENT
Official scientific title PRESERVATION OF THE ANNULO-PAPILLARY CONTINUITY DURING MITRAL VALVE REPLACEMENT
Brief summary describing the background and objectives of the trial effect of preserving the mitral valve apparatus during mitral valve surgery on heart function
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cardiac surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2014
Actual trial start date 01/01/2014
Anticipated date of last follow up 02/05/2018
Actual Last follow-up date 02/05/2017
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 148
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 Non-randomised surgical assessment Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional group complete excision of MV apparatus 59 Active-Treatment of Control Group
Experimental Group partial preservation preserving posterior mitral valve leaflet 45 Active-Treatment of Control Group
Experimental Group complete preservation of MV apparatus Complete preservation of the MV apparatus during MVR 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who had MV surgeries 1- Patients who had MV repair (MVr) rather than replacement. 2- Patients who had significant AV lesion that required correction. 3- Patients with significant coronary artery diseases who required coronary artery bypass grafting (CABG). 16 Year(s) 90 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 16/12/2013 Tanta University Ethical Committee
Ethics Committee Address
Street address City Postal code Country
AlGaish Tanta city Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome heart function left ventricle and right ventricle functions
Secondary Outcome survival after using different techniques to preserve MV apparatus till 6 months after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
waikato DHB Selwyn Street and Pembroke Street hamilton 3204 New Zealand
Tanta university ALGaish Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Ghoneim Egypt
Tanta University el Giesh st Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta university ALGeish St Cardiothoracic Surgery Department- Tanta University Tanta City Egypt University
Primary Sponsor Tanta university ALGeish St Cardiothoracic Surgery Department- Tanta University Tanta City Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed ghoneim ALGeish St Cardiothoracic Surgery Department- Tanta University Tanta City Egypt
Amro Serag ALGeish St Cardiothoracic Surgery Department- Tanta University Tanta city Egypt
Ahmed Ghoneim Algeish St - Cardiothoracic Department- Tanta University tanta City Egypt
Amro Serag ALGeish St Cardiothoracic Surgery Department- Tanta University Tanta city Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Ghoneim ahmed.ghoneim@med.tanta.edu.eg +201117337000 ElGeish st- Cardiothoracic Surgery Department - Tanta University
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Lecturer at Cardiothoracic surgery Department
Role Name Email Phone Street address
Public Enquiries Ahmed Ghoneim ahmed.ghoneim@med.tanta.edu.eg +642040792076 ElGeish st- Cardiothoracic Surgery Department - Tanta University
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Lecturer at Cardiothoracic surgery Department
Role Name Email Phone Street address
Scientific Enquiries Ahmed Ghoneim ahmed.ghoneim@med.tanta.edu.eg +201117337000 ElGeish st- Cardiothoracic Surgery Department - Tanta University
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Lecturer at Cardiothoracic surgery Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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