Pediatric congenital heart disease who are required to heart surgery Complicated congenital heart disease, 3D printing, simulation surgery
Conditions
Interventions
Modification of surgical operation
Surgical operation, modification of surgery
Sponsors
Shiraishi Isao
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Patients with fatal pediatric congenital heart disease who are required to heart surgery. *Patients whose age under 15 years. *Patients with the following congenital heart diseases. Structure of the heart and great vessels is extremely complicated and who required preoperative surgical simulation using 3D heart models. - Double outlet right ventricle - Complete transposition of great arteries - Congenitally corrected transposition of great arteries - Interrupted aortic arch , Coarctation of Aorta - Multiple ventricular septal defect - Single ventricle (include unbalanced atrioventricular septal defect) - Pulmonary atresia (include severe pulmonary stenosis or tetralogy of Fallot with pulmonary atresia) - Hypoplastic left heart syndrome and its related diseases
Exclusion criteria
Exclusion criteria: *Serious condition patients who need urgent cardiac surgery without enough time to manufacture 3D heart models and perform preoperative simulation *Patients who have difficulty in visiting within 30 days after surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of patients who are evaluated as "essential" in Likert scale (post-surgical evaluation in each institute) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Frequency of patients who are evaluated as essential in Likert scale (post-surgical evaluation in the efficacy evaluation committee) 2. Frequency of patients who are evaluated as essential or very useful in Likert scale (post-surgical evaluation in each institute)Frequency of patients who are evaluated as essential in Likert scale (post-surgical evaluation in the efficacy evaluation committee) 3. Frequency of patients who are evaluated as essential or very useful in Likert scale (post-surgical evaluation in the efficacy evaluation committee)4. Comparison of pre-surgical evaluation and post-surgical evaluation in each institute 5. Comparison of evaluation in each institute and evaluation in the efficacy evaluation committee 6. Consistency in anatomical diagnosis between the study device and the heart confirmed at thoracotomy 7. Survival rate at 30 days after surgery 8. Rate of serious adverse events at 30 days after surgery 9. ICU length of stay 10. Presence / absence of auxiliary circulatory system in ICU and its period 11. Cardiac arrest time in surgery 12. Heart-lung machine time in surgery 13. With or without re-operation 14. With or without catheter treatment 15. Transition of tomographic echocardiography results (comparison between pre-surgical results and post-surgical results) 16. Evaluation of neurological development 30 days after surgery (if performed) | — |
Contacts
Public ContactMinori Nakasaki
National Cerebral and Cardiovascular Center
Outcome results
None listed