congenital heart disease
Conditions
Interventions
None listed
Sponsors
Miura Masaru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants of OFT-G1-301 clinical trial
Exclusion criteria
Exclusion criteria: Patients who have indicated their refusal to give written consent, either personally or through a representative. However, if it is difficult to obtain written consent because of transfer to another hospital or for other reasons, a patient who has indicated refusal to provide consent after verbal explanation by telephone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of freedom from reoperation or reintervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety outcomes: adverse events (subjective symptoms, objective findings), echocardiography (also for efficacy evaluation), cardiac catheterization (only when performed due to clinical necessity). Efficacy outcomes: evaluation of the implantation site by echocardiography [existence of residual lesions, cardiac function (left ventricular end-diastolic diameter, left ventricular end-systolic diameter, left ventricular internal diameter shortening rate)/Simpson's method, pulmonary artery diameter change], subjective symptoms with physical activity. | — |
Contacts
Public ContactYoshihiko Morikawa
Tokyo Metropolitan Children's Medical Center
Outcome results
None listed