Therapy evaluation of Rhythm and heart failure with Unified cardiac device Study and Tracking

Therapy evaluation of Rhythm and heart failure with Unified cardiac device Study and Tracking - OCVC TRUST registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059666

Enrollment

1000

Registered

2025-11-06

Start date

2025-12-08

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

Patients receiving first-time implantation of ICD, S-ICD, CRT-P, or CRT-D, as well as those undergoing device upgrades. Includes patients awaiting heart transplantation and those after heart transplantation. If the extravascular implantable cardioverter-defibrillator (EV-ICD) becomes available, that device type will also be included.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who received ICD/S-ICD/CRT-P/CRT-D (and, when available, EV-ICD) implantation at participating sites, including upgrades from pacemakers. Aged 18 years or older. Able to undergo regular follow-up.

Exclusion criteria

Exclusion criteria: Patients with a non-cardiac condition diagnosed as having a life expectancy of <=1 year. Patients who decline to participate in the study. Any other individuals deemed unsuitable by the principal investigator or co-investigators.

Design outcomes

Primary

Measure	Time frame
Composite endpoint comprising major cardiovascular events during the observation period, 3-year all-cause mortality, and hospitalization for heart failure.	—

Secondary

Measure	Time frame
Time-to-event incidence of primary endpoints All-cause mortality Hospitalization for heart failure 5-year composite of all-cause mortality and hospitalization for heart failure Time-to-event incidence of additional clinical outcomes Heart failure-related death + heart failure hospitalization + outpatient intravenous diuretic administration Appropriate device therapies Inappropriate device therapies Device-related complications (e.g., infection, reoperation, cardiac tamponade, vascular perforation, major bleeding) Stroke + systemic embolism Changes in cardiac function (e.g., HFmrEF, cardiomyopathy cases) Changes in exercise capacity (METs) and lead durability in relation to METs VT/VF termination rates according to device programming/reprogramming Effect of left bundle branch area pacing (LBBP) in CRT-P Clinical significance of ventricular tachycardia episodes within the monitoring zone Other outcomes (e.g., frailty; presence of myocardial fibrosis on MRI)	—

Measure

Time frame

Time-to-event incidence of primary endpoints All-cause mortality Hospitalization for heart failure 5-year composite of all-cause mortality and hospitalization for heart failure Time-to-event incidence of additional clinical outcomes Heart failure-related death + heart failure hospitalization + outpatient intravenous diuretic administration Appropriate device therapies Inappropriate device therapies Device-related complications (e.g., infection, reoperation, cardiac tamponade, vascular perforation, major bleeding) Stroke + systemic embolism Changes in cardiac function (e.g., HFmrEF, cardiomyopathy cases) Changes in exercise capacity (METs) and lead durability in relation to METs VT/VF termination rates according to device programming/reprogramming Effect of left bundle branch area pacing (LBBP) in CRT-P Clinical significance of ventricular tachycardia episodes within the monitoring zone Other outcomes (e.g., frailty; presence of myocardial fibrosis on MRI)

—

Countries

Japan

Contacts

Public ContactYohei Sotomi

Graduate School of Medicine, The University of Osaka Department of Cardiovascular Medicine

sotomi.yohei.med@osaka-u.ac.jp0668795111

Outcome results