NIPH Clinical Trials Search

Investigation of the relationship between Heart Insight and heart failure exacerbation

Basic Information

Recruitment status	Not Recruiting
Health condition(s) or Problem(s) studied	heart failure, ventricular tachycardia, ventricular fibrillation
Date of first enrollment	20/05/2024
Target sample size	400
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome	Sensitivity and specificity of Heart Insight for heart failure exacerbation
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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