臨床研究等提出・公開システム

Date of registration	May. 01, 2026
Last modified on	May. 01, 2026
Trial ID	jRCT1042260020

Scientific Title	Investigating the relevance of Heart Insight with multi-parameter score and Heart Failure in real clinical practice
Public Title	Investigation of the relationship between Heart Insight and heart failure exacerbation

Contact for Scientific Queries	Name	Inden Yasuya
	Affiliation	Nagoya University Graduate School of Medicine
	Address	65 Tsurumai, Showa, Nagoya, Aichi
	Telephone	+81-52-744-2147
	E-mail	inden@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Shimojo Masafumi
	Affiliation	Nagoya University Graduate School of Medicine
	Address	65 Tsurumai, Showa, Nagoya, Aichi
	Telephone	+81-52-744-2147
	E-mail	shimojom@med.nagoya-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Feb. 20, 2024
Actual date of first enrollment		May. 20, 2024
Target sample size		400
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients Eligible for Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Based on the Joint Guidelines of the Japanese Circulation Society and the Japanese Heart Rhythm Society. 2. Patients who have had a BIOTRONIK ICD or CRT-D with HI capability implanted on or after March 19, 2019, and are already using it with home monitoring, or those who are scheduled for implantation and can use home monitoring. 3. Patients who, due to clinical necessity, have the HI function set to ON, have provided consent to participate in this study, and are able to undergo standard follow-up for one year.
	Exclusion Criteria	1. Patients who cannot use the HI score 2. Patients who cannot attend regular follow-up visits 3. Patients who do not understand the purpose of the study 4. Patients under 18 years old or those under guardianship
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		heart failure, ventricular tachycardia, ventricular fibrillation
Health Condition(s) Keyword		heart failure, ventricular tachycardia, ventricular fibrillation
Health Condition(s) Code		D006333, D017180, D014693
Primary Outcome(s)		Sensitivity and specificity of Heart Insight for heart failure exacerbation
Secondary Outcome(s)		1. Occurrence of ventricular arrhythmias 2. Consistency of arrhythmia detection by ICD and CRT-D 3. Number of days from HI alert to therapeutic intervention

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Nagoya University Certified Review Board
Address	65 Tsurumai, Showa, Nagoya, Aichi, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 20, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None