UMIN-ICDS Clinical Trial

Public title

A Registry Study of Patients with Cardiac Implantable Electronic Devices

Acronym

CIED Regsistry

Scientific Title

A Prospective Registry Study of Patients with Cardiac Implantable Electronic Devices

Scientific Title:Acronym

CIED Regsistry

Region

Japan

Condition

Inpatients and outpatients with cardiac implantable electronic devices (pacemakers, ICDs, CRT-Ps, CRT-Ds)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the prevalence of heart failure (particularly HFpEF) in patients with cardiac implantable electronic devices, overall prognosis, and long-term outcomes of conduction system pacing (CSP)

Basic objectives2

Others

Basic objectives -Others

To investigate the relationship between the heart-rate setting and quality of life (QOL)

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

A composite endpoint of death or worsening heart failure (hospitalization or emergency outpatient visit)

Key secondary outcomes

Stroke and systemic embolism
Comprehensive Questionnaire on Quality of Life in Heart Failure (MLHFQ)
Left ventricular ejection fraction (LVEF)
Cumulative duration of atrial fibrillation (AF burden)

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with implanted pacemakers (transvenous, leadless), ICDs, CRT-P devices or CRT-D devices

Key exclusion criteria

Severe organic valvular heart disease
Serious complications (malignant diseases with a predicted prognosis of less than one year, severe chronic obstructive pulmonary disease, haemodialysis)
Pregnancy
Any other patients deemed unsuitable as study participants by the principal investigator or co-investigators

Target sample size

550

Name of lead principal investigator

1st name	Hidemori
Middle name
Last name	Hayashi

Organization

Juntendo University Hospital

Division name

Department of Cardiology

Zip code

1138421

Address

2-1-1 Hongo, Bunkyo-Ku, Tokyo

TEL

03-3813-3111

Email

hhayashi@juntendo.ac.jp

Name of contact person

1st name	Hidemori
Middle name
Last name	Hayashi

Organization

Juntendo University Hospital

Division name

Department of Cardiology

Zip code

113-8421

Address

2-1-1 Hongo, Buryo-Ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

hhayashi@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

Medtronic Japan Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee Faculty of Medicine, Juntendo University

Address

3-1-3 Hongo, Bunkyo-Ku, Tokyo

Tel

03-5802-1584

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

08

Month

07

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

Open public recruiting

Date of protocol fixation

2026

Year

05

Month

29

Day

Date of IRB

2026

Year

07

Month

28

Day

Anticipated trial start date

2026

Year

08

Month

07

Day

Last follow-up date

2032

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study 1: A retrospective cross-sectional study on the prevalence of heart failure and device settings
In cases where echocardiography data were available, patients with HFrEF (LVEF <=40%), HFmrEF (40% < LVEF < 50%), and HFpEF (LVEF >=50%, H2-FPEF score >=6 or HFA-PEFF score >=5); the BREATH2 score; pacing modes; set rates; and the rates of standard drug therapy (GDMT) and remote monitoring.

Study 2: A prospective observational study on the association between programmed lower rate and quality of life (written informed consent will be obtained for the questionnaire survey).
We will prospectively evaluate the association between the programmed lower rate and pacing site used in routine clinical practice (right ventricle, His bundle, left bundle branch area, and left ventricle) and quality of life (MLHFQ), physical activity, NT-proBNP, echocardiographic parameters (LVEF, E/e', LAVI), AF burden, and thoracic impedance. No pacemaker settings will be modified for research purposes.

Study 3: A longitudinal study on the long-term clinical outcomes of patients with implantable cardiac devices (a retrospective cohort study based on existing data, with follow-up for the next five years)
For patients enrolled in Study 1, regardless of the presence or absence of heart failure, we will assess mortality, events of heart failure exacerbation, stroke or systemic embolism at one-year intervals from enrolment. Furthermore, we will conduct subgroup analyses regarding the effects of CSP on LVEF and AF burden.

Registered date

2026

Year

08

Month

07

Day

Last modified on

2026

Year

08

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071566