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Investigation of the relationship between Heart Insight and heart failure exacerbation

Investigating the relevance of Heart Insight with multi-parameter score and Heart Failure in real clinical practice

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1042260020
Enrollment
400
Registered
2026-05-01
Start date
2024-05-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure, ventricular tachycardia, ventricular fibrillation heart failure, ventricular tachycardia, ventricular fibrillation

Interventions

None listed

Sponsors

Inden Yasuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of Heart Insight for heart failure exacerbation

Secondary

MeasureTime frame
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

Contacts

Public ContactMasafumi Shimojo

Nagoya University Graduate School of Medicine

shimojom@med.nagoya-u.ac.jp+81-52-744-2147

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026