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IRCT20161220031496N2 IRCT 2022-04-14 Shiraz University of Medical Sciences Evaluation of right atrial appendage valve in TOF Evaluation of mid-term results of pulmonary valve reconstruction using right atrial appendage among children with tetralogy of Fallot 2022-04-30 anticipated 20 Complete https://irct.ir/trial/62709 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Condition 1: Tetralogy Fallot. Condition 2: Pulmonary valve regurgitation. Condition 3: Pulmonary valve stenosis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: The surgical procedure as well as all the echocardiographic and ECG data will be provided in detail. When: unlimited To whom: All cardiac surgeons and cardiologists in the world Conditions: To improve the surgery of tetralogy of Fallot Where to obtain: Apply by email to the scientific or general manager of this project How to obtain: After a written request by email from the applicants, it will be provided to them by the scientific manager Comments:
public Mohammadreza Edraki
Namazi Hospital- Zand Blvd
Shiraz Iran (Islamic Republic of) 7193613311 009836474332 edrakimr@sums.ac.ir Shiraz University of Medical Sciences scientific Ahmadali Amirghofran
Faghihi Hospital- Zand Blvd
Shiraz Iran (Islamic Republic of) 7134846114 009832351087 amirghofranaa@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 6 months 2 years Both Patients with small right atrial appendage Patients who have previously had heart surgery Patient with conduction anomalies Q21.3 I37.2 I37.2 Tetralogy of Fallot Nonrheumatic pulmonary valve stenosis with insufficiency Nonrheumatic pulmonary valve stenosis with insufficiency Treatment - Surgery Treatment - Surgery 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. 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. Neo pulmonary valve stenosis. Timepoint: Q 6 months. Method of measurement: Transthoracic Echocardiography. Neo pulmonary valve stenosis. Timepoint: Q 6 months. Method of measurement: Transthoracic echocardiography. Possibility of conduction disturbances. Timepoint: Q 6 months. Method of measurement: ECG. Shiraz University of Medical Sciences Approved 2022-04-06 Shiraz University of Medical Sciences Zand Blvd Shiraz Fars Iran (Islamic Republic of)