臨床研究等提出・公開システム

Date of registration	Dec. 21, 2023
Last modified on	April. 07, 2026
Trial ID	jRCT1030230523

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

Contact for Scientific Queries	Name	Miura Masaru
	Affiliation	Tokyo Metropolitan Children's Medical Center
	Address	2-8-29, Musashidai, Fuchu-shi, Tokyo
	Telephone	+81-42-300-5111
	E-mail	masaru_miura@tmhp.jp
Contact for Public Queries	Name	Morikawa Yoshihiko
	Affiliation	Tokyo Metropolitan Children's Medical Center
	Address	2-8-29, Musashidai, Fuchu-shi, Tokyo
	Telephone	+81-42-300-5111
	E-mail	morikawa@2005.jukuin.keio.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 21, 2023
Target sample size		34
Study Type		Observational
Key inclusion & exclusion criteria	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.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		congenital heart disease
Primary Outcome(s)		The rate of freedom from reoperation or reintervention.
Secondary Outcome(s)		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.

Primary Sponsor	Tokyo Metropolitan Children's Medical Center

Secondary Sponsor

Source of Monetary Support	TEIJIN LIMITED
Secondary Sponsor	Not applicable

Name of Certified Review Board	The Ethics Committee of Tokyo Metropolitan Children's Medical Center
Address	2-8-29, Musashidai, Fuchu-shi, Tokyo, Tokyo
Telephone	+81-42-300-5111
E-Mail	sn_erb@tmhp.jp
Approval Status	Approval
Date of approval	Oct. 16, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	April. 07, 2026	(this page)	Changes
5	Oct. 10, 2024	Detail	Changes
4	Sept. 19, 2024	Detail	Changes
3	May. 16, 2024	Detail	Changes
2	April. 17, 2024	Detail	Changes
1	Dec. 21, 2023	Detail

List of change history