Congenital heart diseases with complex 3D structures requiring heart surgery to sustain life.
Conditions
Interventions
By objectively analyzing patients' clinical information using high-performance computers and predicting postoperative outcomes for various surgical procedures based on these results, it supports the s
Sponsors
Shiraishi Isao
Eligibility
Inclusion criteria
Inclusion criteria: 1) Pediatric patients requiring cardiac repair surgery for life-sustaining purposes 2) Patients under 15 years of age (at the time of obtaining consent from a legal representative) 3) Patients requiring cardiac catheterization, cardiovascular angiography, or cardiac CT angiography for diagnosis and treatment planning. Or patients who underwent cardiac catheterization, cardiovascular angiography, or cardiac CT angiography prior to surgery (To avoid repeated X-ray exposure and unnecessary anesthesia/sedation in pediatric patients, data may be accepted for patients under 2 years of age if echocardiography, cardiac CT, cardiac catheterization/cardiovascular angiography, and pulmonary perfusion scintigraphy (if necessary) were performed within 180 days prior to surgery, no subsequent surgical intervention occurred, and no significant hemodynamic changes were determined. For pediatric patients aged 2 years or older, if the above examinations were performed within one year prior to surgery, no subsequent surgical intervention has been performed, and electrocardiogram (ECG) and echocardiography indicate no significant hemodynamic changes, the examination results may be accepted.) 4) Patients scheduled for congenital heart disease surgery within 180 days after obtaining consent. 5) Pediatric patients with complex congenital heart disease involving intricate three-dimensional structures of the heart and great vessels, for whom preoperative simulation using this device enables more precise determination of the surgical approach. Representative disease names are listed below. (1) Tetralogy of Fallot (including pulmonary atresia with ventricular septal defect and pulmonary atresia) (2) Double outlet right ventricle (3) Complete transposition of the great arteries (4) Corrected transposition of the great arteries (5) Coarctation of Aorta/Interrupted Aortic Arch (6) Hypoplastic left heart syndrome and related conditions (7) Single ventricle and visceral heterotaxy syndrome (8) Persistent Truncus Arteriosus (9) Complex congenital heart disease not classified under (1)-(8) above, where determining the surgical approach is difficult using conventional methods and simulation using this device is expected to be useful for determining the surgical approach 6) Patients for whom written consent for participation in this clinical trial has been obtained from the patient's legal representative (parent or guardian, or equivalent)
Exclusion criteria
Exclusion criteria: 1) Patients with severe conditions who may require urgent or semi-urgent cardiac repair surgery before the results of this clinical trial preparation and simulation using the ped UT-Heart system are obtained 2) Patients with allergies to the contrast medium used during cardiac CT examinations and cardiac catheterization/cardiovascular angiography 3) Patients for whom follow-up until 30 days post-surgery is difficult 4) Patients deemed ineligible for participation in this trial by the principal investigator (or sub-investigator).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative overall assessment of the usefulness of ped UT-Heart in assisting surgical procedure selection, as evaluated by the principal investigator (or co-investigator) (rated as Essential or Very useful on the Likert scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| [Efficacy Evaluation Items] 1) Survival rate at 30 days post-surgery 2) Length of stay in the ICU 3) Use of extracorporeal membrane oxygenation (ECMO) in the ICU and its duration 4) Cardiac arrest time during surgery 5) Cardiopulmonary bypass time during surgery 6) Need for reoperation 7) Need for catheter-based intervention 8) Changes in Transesophageal Echocardiography Findings (Preoperative vs. Postoperative Comparison) 9) Assessment of Neurological Development at 30 Days Postoperatively (if performed) 10) Changes in Cardiac CT Findings (Confirmation of Postoperative Cardiovascular Morphology) 11) Prediction of Postoperative Clinical Findings [Evaluation Items Regarding the Usefulness of ped UT-Heart] 1) Postoperative overall evaluation of ped UT-Heart's usefulness in assisting surgical procedure selection, as assessed by the Usefulness Evaluation Committee (rated as Essential or Very useful on the Likert scale) 2) Preoperative anticipated evaluation of ped UT-Heart's usefulness in assisting surgical procedure selection, as assessed by the principal investigator (or co-investigator) performing the surgery (rated as Essential or Very useful on the Likert scale) 3) Comparison between the preoperative anticipated assessment and postoperative overall assessment of ped UT-Heart's usefulness in assisting surgical procedure selection by the principal (or co-principal) investigator surgeon, and the postoperative overall assessment by the Usefulness Evaluation Committee (Likert scale) 4) Comparison between the preoperative anticipated assessment and postoperative overall assessment of ped UT-Heart's usefulness in assisting surgical procedure selection by the principal (or co-principal) investigator surgeon (Likert scale) 5) Comparison of the confidence level in surgical procedure selection before and after simulation using ped UT-Heart, as assessed by the principal investigator (or co-investigator) who performed the surgery (Numerical Rating Scale) 6) Reliability of ped | — |
Contacts
Public ContactIsao Shiraishi
National Cerebral and Cardiovascular Center
Outcome results
None listed