臨床研究等提出・公開システム

Date of registration	Feb. 14, 2025
Last modified on	Feb. 14, 2025
Trial ID	jRCT1042240190

Scientific Title	PSR-CRHF: Enlighten Japan
Public Title	PSR-CRHF: Enlighten Japan

Contact for Scientific Queries	Name	Yamamoto Takuto
	Affiliation	Medtronic Japan
	Address	Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
	Telephone	+81-80-4671-6498
	E-mail	takuto.yamamoto@medtronic.com
Contact for Public Queries	Name	Yamamoto Takuto
	Affiliation	Medtronic Japan
	Address	Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
	Telephone	+81-80-4671-6498
	E-mail	takuto.yamamoto@medtronic.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 01, 2025
Target sample size		300
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements Patient has or is intended to receive or be treated with an eligible Medtronic product Patient is consented within the enrollment window of the therapy received
	Exclusion Criteria	Patient who is, or is expected to be, inaccessible for follow-up Participation is excluded by local law Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cardiac Arrhythmias
Primary Outcome(s)		Characterize the freedom from major complications related to the Aurora EV-ICD System and/or procedure at 2-years post implant
Secondary Outcome(s)		- Estimate the Aurora EV-ICD major system and/or procedure related complication-free survival probability as a function of time post-implant - Characterize the rate of abnormal battery depletion complications as a function of time post-implant - Summarize all device system revisions (e.g., reposition, replacement, explant) including reasons for modification and action taken - Summarize patient deaths - Summarize patient demographics and baseline medical history - Characterize extracardiac pacing sensation - Summarize ATP with spontaneous arrhythmias - Characterize asystole pacing - Characterize sensing and detection - Characterize defibrillation shock effectiveness for terminating spontaneous VT/VF arrhythmia

Primary Sponsor	Medtronic Japan

Name of Certified Review Board	Central Ethical Committee of Japanese Association for the Promotion of State-of-the-Art in Medicine (JAPSAM)
Address	1205 Chigusa Tower Hills, 2-24-2 Chigusa, Chikusa-ku, Nagoya, Aichi
Telephone	+81-52-745-6881
E-Mail	info-irb@japsam.or.jp

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none