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.
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.