Congenital heart disease
Conditions
Interventions
investigational material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : Take out the patch from the p
Sponsors
TEIJIN LIMITED / TEIJIN PHARMA LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Patient with congenital heart disease requiring thoracotomy. - Patient who has at least 1 site in any of the septum, the outer wall and the vascular wall to be repaired. - Patient or the patient's legally acceptable representative who gives the written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Patient requiring emergency surgery. - Patient with non-cardiac disease significantly raising surgical risk, significant non-cardiac disease with life expectancy less than 6 months, or progressive non-cardiac disease (liver failure, renal failure, cancer, etc.). - Patient who has coagulation test abnormality. - Patient who has familial arrhythmia. - Patient who has arrhythmia observed on preoperative ECG diagnosis. - Patient who is pregnant or lactating at the time of the consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety - The success rate of the surgery in a year after the surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - Presence or absence of residual disease detected by echocardiography. - Cardiac function evaluation by echocardiography. | — |
Countries
Japan
Outcome results
None listed