UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019497
Receipt number R000022484
Scientific Title Investigation on the Relationship of SAM-RDI and PAC or PVC in Pacemaker Implant Patients
Date of disclosure of the study information 2015/10/26
Last modified on 2023/11/01 10:24:03

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Basic information

Public title

Investigation on the Relationship of SAM-RDI and PAC or PVC in Pacemaker Implant Patients

Acronym

Investigation on the Relationship of SAM-RDI and PAC or PVC in Pacemaker Implant Patients

Scientific Title

Investigation on the Relationship of SAM-RDI and PAC or PVC in Pacemaker Implant Patients

Scientific Title:Acronym

Investigation on the Relationship of SAM-RDI and PAC or PVC in Pacemaker Implant Patients

Region

Japan


Condition

Condition

Patients who has been implanted pacemaker

Classification by specialty

Cardiology Vascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate the number of documented PAC PVC(/day) and SAM-RDI value.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

SAM-RDI Value
Number of documented premature atrial contraction (/day)
Number of documented premature ventricular contraction (/day)

Key secondary outcomes



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 Patient eligible for implantation of an DDD device according to JCS guideline.

2 Patient who has been implanted with Sorin pacemaker (KORA100 DR or REPLY200 DR).

Key exclusion criteria

1 Permanent or persistent atrial tachy arrhythmia.
2 The patient who is within 1 month from the last pacemaker follow-up day.
3 Patient is pregnant.
4 Age of less than 20 years old.

Target sample size

304


Research contact person

Name of lead principal investigator

1st name Toshitaka
Middle name
Last name Ogata

Organization

Japan lifeline Co.,Ltd.

Division name

CRM Markting Dvision

Zip code

1400002

Address

6F Tennoz Central Twower 2-2-24 Higashishinagawa Shinagawa-ku Tokyo

TEL

03-6711-5230

Email

t-ogata@jll.co.jp


Public contact

Name of contact person

1st name Toshitaka
Middle name
Last name Ogata

Organization

Japan lifeline Co.,Ltd.

Division name

CRM Markting Dvision

Zip code

1400002

Address

6F Tennoz Central Twower 2-2-24 Higashishinagawa Shinagawa-ku Tokyo

TEL

03-6711-5230

Homepage URL


Email

t-ogata@jll.co.jp


Sponsor or person

Institute

Japan lifeline Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Japan lifeline Co.,Ltd.

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

Japan lifeline Co.,Ltd.

Address

25F NYK Tennoz Bild 2-2-20 Higashishinagawa Shinagawa-ku Tokyo

Tel

03-6711-5263

Email

m-nomura@jll.co.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

2015 Year 10 Month 26 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


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 04 Month 01 Day

Date analysis concluded

2016 Year 10 Month 01 Day


Other

Other related information

none


Management information

Registered date

2015 Year 10 Month 26 Day

Last modified on

2023 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022484


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name