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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032242
Receipt No. R000036766
Scientific Title Effect of Adherence to Remote Monitoring on Early Detection of Arrhythmic and Alert Events in Pacemaker Patients: a double-blind Randomized, Crossover Study Comparing the Control and the Remote Monitoring Center
Date of disclosure of the study information 2018/04/13
Last modified on 2018/04/13

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Basic information
Public title Effect of Adherence to Remote Monitoring on Early Detection of Arrhythmic and Alert Events in Pacemaker Patients:
a double-blind Randomized, Crossover Study Comparing the Control and the Remote Monitoring Center
Acronym Effect of Adherence to Remote Monitoring on Early Detection of Arrhythmic and Alert Events in Pacemaker Patients
Scientific Title Effect of Adherence to Remote Monitoring on Early Detection of Arrhythmic and Alert Events in Pacemaker Patients:
a double-blind Randomized, Crossover Study Comparing the Control and the Remote Monitoring Center
Scientific Title:Acronym Effect of Adherence to Remote Monitoring on Early Detection of Arrhythmic and Alert Events in Pacemaker Patients
Region
Japan

Condition
Condition Bradyarrhythmias
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate effect of adherence to remote monitoring on early detection of arrhythmic and alert events
in pacemaker patients and compared the effect between the control and the remote monitoring center group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes adherence to remote monitoring during 1 year after the enrollment
Key secondary outcomes alert events during 1 year after the enrollment

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 the remote monitoring center
Interventions/Control_2 the control (each institution)
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 or IIa indication for pacemaker implant by the guideline of the Japanese circulation society
2) Within 30 days after implant of pacemaker
3) acceptance of the remote monitoring follow-up during 1 year after the enrollment
4) Equal and more than 20 years old at implant
Key exclusion criteria 1) Class III indication for pacemaker implant by the guideline of the Japanese circulation society
2) The enrollment to the other clinical trials
3) Within 1 year of estimated lifetime
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Soejima
Organization Kyorin university school of medicine
Division name Cardiology
Zip code
Address 6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL 0422-47-5511
Email skyoko@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Sato
Organization Kyorin university school of medicine
Division name Division of Advanced Arrhythmia Management
Zip code
Address 6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL 0422-47-5511
Homepage URL
Email toshiaki_sato@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin university school of medicine
Institute
Department

Funding Source
Organization Kyorin university school of medicine cardiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 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
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 13 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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