Making a pulmonary valve from the autologous right atrial appendage of the patients with tetralogy of Fallot and implanting this valve instead of the patient's own pulmonary valve
Design
In this clinical trial with a control group, for 20 patients, a pulmonary valve is made using the autologous right atrial appendage and compared with 20 patients with a trans-pulmonary annular patch method.
Settings and conduct
Following tetralogy of Fallot surgery, pulmonary valve insufficiency may be severe, and after a while a new pulmonary valve may need to be implanted. The new valve will become stenotic and insufficient and will need to be replaced. A new valve can be made in Shiraz, which is made of the autologous right atrial appendage with no fixative such as formaldehyde. If this new valve survives and grows as the patient grows, there is a possibility of no valve failure and stenosis, and therefore right ventricular failure is reduced and the possibility of the need for pulmonary valve implantation in the coming years is reduced. To prepare this valve, the appendage is first cut and stored in saline solution, then closed with sutures. The connecting muscle strips inside the RAA are cut to separate the two layers. All the larger muscle strips are carefully cut to make the layers thinner and more flexible.
The valve is then inserted into the RVOT.
These patients are compared with patients who have undergone transannular patch surgery by echocardiography and ECG every 6 months.
Participants/Inclusion and exclusion criteria
study participants are children with tetralogy of Fallot. Inclusion criteria include tetralogy of Fallot patients who have not previously had heart surgery and do not have a conduction disorder.
Intervention groups
Children with the impression of tetralogy of Fallot
Evaluation of mid-term results of pulmonary valve reconstruction using right atrial appendage among children with tetralogy of Fallot
Public title
Evaluation of right atrial appendage valve in TOF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fallot tetralogy patients whose pulmonary valve needs to be repaired
Fallot tetralogy patients who need insertion of a conduit
Fallot tetralogy patients who need a transannular patch
Exclusion criteria:
Patients with small right atrial appendage
Patients who have previously had heart surgery
Patient with conduction anomalies
Age
From 6 months old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-04-06, 1401/01/17
Ethics committee reference number
IR.SUMS.MED.REC.1401.006
Health conditions studied
1
Description of health condition studied
Tetralogy Fallot
ICD-10 code
Q21.3
ICD-10 code description
Tetralogy of Fallot
2
Description of health condition studied
Pulmonary valve regurgitation
ICD-10 code
I37.2
ICD-10 code description
Nonrheumatic pulmonary valve stenosis with insufficiency
3
Description of health condition studied
Pulmonary valve stenosis
ICD-10 code
I37.2
ICD-10 code description
Nonrheumatic pulmonary valve stenosis with insufficiency
Primary outcomes
1
Description
Neo pulmonary valve stenosis
Timepoint
Q 6 months
Method of measurement
Transthoracic Echocardiography
2
Description
Neo pulmonary valve stenosis
Timepoint
Q 6 months
Method of measurement
Transthoracic echocardiography
3
Description
Possibility of conduction disturbances
Timepoint
Q 6 months
Method of measurement
ECG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the first time the pulmonary valve repair in children with tetralogy of Fallot, we make an autologous valve for the patients and it is assumed that this valve grows with age and does not suffer from stenosis and insufficiency, and this surgical method Improves patients' lives. We hope that in this study we will obtain acceptable results from the function of this new valve as a pulmonary valve. This valve is made of the patient's right atrium at the time of surgery. And the possibility of new pulmonary valve insufficiency and stenosis may decrease, and therefore right ventricular failure in these patients decreases, and the possibility of the need for pulmonary valve implantation in the coming years for these patients also decreases. The appendage is clamped and is cut over the clamp and kept in a saline solution. The right atrial stamp is closed by suturing in two layers, first a mattress row under the vascular clamp and then an over-and-over suture run after removing the clamp. All the larger muscle bands are accurately excised to make the layers thinner and more pliable. The smaller muscle tissues are left in place to prevent accidental perforation of the cusps. The valve is now placed instead of the pulmonary valve, with the proximal end positioned at the annulus level and the distal end toward the pulmonary artery bifurcation. In cases with very short main pulmonary arteries, care should be taken not to obstruct the orifice of the right pulmonary artery by our valve tissue.20 patients will be operated with this method.
Category
Treatment - Surgery
2
Description
Control group: Children with tetralogy of Fallot who correspond to the intervention group in different conditions and we will operate on them with the conventional pulmonary transnnular patch method, will be studied as this group. In this surgical procedure that has been done in the world for years, we make an incision in the right ventricular outflow tract towards the pulmonary valve, which continues to the pulmonary artery. The gap is then covered with a pericardial patch. Therefore, the pulmonary valve loses its activity in this method and the patient suffers from pulmonary valve insufficiency. 20 patients will be operated with this conventional method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi teaching Hospital
Full name of responsible person
Ahmadali Amirghofran
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour ( Research assistant of the University))
Street address
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadreza Edraki
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Namazi Hospital- Zand Blvd
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
009836474332
Email
edrakimr@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmadali Amirghofran
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Faghihi Hospital- Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
009832351087
Email
amirghofranaa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadreza Edraki
Position
Associate Proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Namazi Hospital- Zand Blvd
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
009836474326
Email
edrakimr@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The surgical procedure as well as all the echocardiographic and ECG data will be provided in detail.
When the data will become available and for how long
unlimited
To whom data/document is available
All cardiac surgeons and cardiologists in the world
Under which criteria data/document could be used
To improve the surgery of tetralogy of Fallot
From where data/document is obtainable
Apply by email to the scientific or general manager of this project
What processes are involved for a request to access data/document
After a written request by email from the applicants, it will be provided to them by the scientific manager