UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040583
Receipt number R000046319
Scientific Title Registry of Conduction System Pacing
Date of disclosure of the study information 2021/04/13
Last modified on 2023/10/14 17:04:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Registry of Conduction System Pacing

Acronym

Registry of Conduction System Pacing

Scientific Title

Registry of Conduction System Pacing

Scientific Title:Acronym

Registry of Conduction System Pacing

Region

Japan


Condition

Condition

Atrioventricular (AV) block

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the current status of Conduction System Pacing for patients with atrioventricular block

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Conduction System Pacing implantation results

Key secondary outcomes

Postoperative complications
1 year after implantation (device information, existence of survival)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Class I, IIa,or IIb indications for pacing therapy for atrioventricular block of II degrees or higher
2.Echocardiographic left ventricular contractility (Ejection fraction: EF)> 35%

Key exclusion criteria

1.Age under 20 at the time of implantation
2.Patients who could not obtain consent to participate in the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Eriko
Middle name
Last name Hasumi

Organization

The University of Tokyo Hospital

Division name

Department of Cardiovascular Medicine

Zip code

113-8655

Address

7-3-1 Hngo Bunkyo-ku Tokyo

TEL

03-3815-5411

Email

ehasmi-circ@umin.ac.jp


Public contact

Name of contact person

1st name Eriko
Middle name
Last name Hasumi

Organization

The University of Tokyo Hospital

Division name

Department of Cardiovascular Medicine

Zip code

113-8655

Address

7-3-1 Hngo Bunkyo-ku Tokyo

TEL

03-3815-5411

Homepage URL


Email

ehasmi-circ@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Medtronic

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo Hospital

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-3815-5411

Email

ethics@m.u-tokyo.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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

None

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 03 Month 03 Day

Date of IRB

2020 Year 04 Month 22 Day

Anticipated trial start date

2020 Year 05 Month 12 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A prospective observational study


Management information

Registered date

2020 Year 05 Month 29 Day

Last modified on

2023 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046319


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name