A prospective multicenter observational study of participants enrolled in the cardiovascular patch "SYNFOLIUM" clinical trial

JRCT ID: jRCT1030230523

Registered date:21/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: congenital heart disease
• Date of first enrollment: 21/12/2023
• Target sample size: 34
• Study type: Observational

Outcome(s)

• Primary Outcome: The rate of freedom from reoperation or reintervention.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Participants of OFT-G1-301 clinical trial
• Exclude 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.

Related Information

• Primary Sponsor: Miura Masaru
• Source(s) of Monetary Support: TEIJIN LIMITED