Development of ped UT-Heart

JRCT ID: jRCTs052210139

Registered date:22/12/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Congenital heart disease patients with extremely complex three-dimensional structure of the heart.
• Date of first enrollment: 18/03/2022
• Target sample size: 15
• Study type: Interventional

Intervention(s)

To simulate and suggest to surgeons the postoperative hemodynamics of multiple possible surgical
techniques based on preoperative cardiac morphology and hemodynamics.

Outcome(s)

• Primary Outcome: Overall postoperative evaluation of the usefulness of ped UT-Heart in assisting in the choice of procedure as assessed by the surgeon (Essential or Very useful on the Likert scale)

Secondary Outcome

1. survival rate at 30 days after surgery
2. length of stay in ICU
3. presence and duration of assisted circulation in ICU
4. cardiac arrest time in surgery
5. cardiopulmonary resuscitation time in surgery
6. reoperation or not
7. catheterization or not
8. changes in the results of cross-sectional echocardiography (preoperative and 30-day postoperative comparison)
9. assessment of neurological development at 30 days postoperatively (if performed)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 15age old
• Gender: Both

Include criteria

(1) Patients with pediatric congenital heart disease requiring life-sustaining cardiac repair surgery.
(2) Patients under 15 years of age (when consent is obtained from a substitute).
(3) Patients who need to undergo cardiac catheterization, cardiovascular angiography, and MSCT
angiography to determine the diagnosis and treatment plan.
(4) Patients scheduled to undergo surgery for congenital heart disease within 180 days of obtaining consent.
(5) Patients with the following congenital heart diseases in which the three-dimensional structure of the
heart and great vessels are extremely complicated.
1. Double outlet right ventricle
2. Complete transposition of the great arteries
3. Congenitally corrected transposition of the great arteries
4. Coarctation of aorta/ Interrupted aortic arch
5. Ventricular septal defect with multiple defects
6. Univentricular Heart (including complete atrioventricular septal defect with unbalanced ventricles)
7. Tetralogy of Fallot with or without pulmonary atresia
8. Hypoplastic left heart syndrome and its analogs

Exclude criteria

(1) Critically ill patients who may require urgent cardiac repair surgery before the simulation using the ped
UT-Heart system is available.
(2) Patients who are allergic to contrast media used in MSCT and cardiac catheterization/angiography.
(3) Patients for whom follow-up until 30 days after surgery is difficult.
(4) Patients who are judged by the principal investigator to be unsuitable for participation in this study.

Related Information

• Primary Sponsor: Kurosaki Kenichi
• Secondary Sponsor: Hisada Toshiaki,PIA Co.,Ltd,Japan Medical Device Corporation
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development