UMIN-CTR Clinical Trial

Public title

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

Acronym

OCVC TRUST registry

Scientific Title

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

Scientific Title:Acronym

OCVC TRUST registry

Region

Japan

Condition

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.

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will establish a large, multicenter database in the continuously evolving fields of heart failure, arrhythmias, and device therapy to keep treatment strategies updated to the state of the art. Using long-term, large-scale multicenter data, we will conduct integrated analyses of patient characteristics, pathophysiologic assessments, and outcome information to:
1.Continuously refine optimal interventional and pharmacologic therapies.
2.Examine the relationships between patient factors and clinical outcomes.
3.Explore optimization of healthcare systems and societal resources.
4.Collect clinical data to enable real-world implementation of biomedical informatics and AI technologies.
Through these long-term, multifaceted investigations, our goal is to generate insights that promote earlier diagnosis and detection and ultimately improve patient outcomes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

120

years-old

>=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

1000

Name of lead principal investigator

1st name	Yasushi
Middle name
Last name	Sakata

Organization

Graduate School of Medicine, The University of Osaka

Division name

Department of Cardiovascular Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

0668795111

Email

sakata.yasushi.med@osaka-u.ac.jp

Name of contact person

1st name	Yohei
Middle name
Last name	Sotomi

Organization

Graduate School of Medicine, The University of Osaka

Division name

Department of Cardiovascular Medicine

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

0668795111

Homepage URL

Email

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

Institute

The univerity of Osaka

Institute

Department

Personal name

Organization

Medtronic

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

The University of Osaka

Address

2-2 Yamadaoka, Suita, Osaka, Japan

Tel

0662108296

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Osaka

Institutions

Date of disclosure of the study information

2025

Year

11

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

03

Month

21

Day

Date of IRB

Anticipated trial start date

2025

Year

12

Month

08

Day

Last follow-up date

2036

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Prospective observational registry. No study-mandated interventions; treatments and device programming are at the discretion of the treating physician (standard of care). Eligible participants are adults (>=18 years) who undergo first-time implantation or an upgrade to ICD/S-ICD/CRT-P/CRT-D (and, when available, EV-ICD) at participating sites. Follow-up is conducted at admission, the perioperative period, postoperatively/at discharge, 6 months, 12 months, and annually thereafter for up to 5 years. Data collected include demographics, comorbidities, device and lead information and programming, test findings (ECG, echocardiography, NT-proBNP, etc.), and clinical events. Primary endpoints are all-cause mortality, hospitalization for heart failure, and the 5-year composite of all-cause mortality and hospitalization for heart failure. Secondary outcomes include appropriate and inappropriate device therapies, device-related complications, stroke plus systemic embolism, functional measures (e.g., HFmrEF), exercise capacity, and VT/VF termination rates. Data are managed in an electronic data capture (EDC) system using anonymized study IDs.

Registered date

2025

Year

11

Month

06

Day

Last modified on

2025

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068131