A prospective multicenter observational study of participants enrolled in the cardiovascular patch SYNFOLIUM clinical trial
Phase 4
Recruiting
- Conditions
- congenital heart disease
- Registration Number
- JPRN-jRCT1030230523
- Lead Sponsor
- Miura Masaru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Participants of OFT-G1-301 clinical trial
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of freedom from reoperation or reintervention.
- Secondary Outcome Measures
Name Time Method Safety outcomes: adverse events (subjective symptoms, objective findings), echocardiography (also for efficacy evaluation), cardiac catheterization (only when performed due to clinical necessity).<br>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.