UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032242 |
|---|---|
| Receipt number | 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 | 2020/06/02 08:33:46 |
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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 | Kyoko |
| Middle name | |
| Last name | Soejima |
Organization
Kyorin university school of medicine
Division name
Cardiology
Zip code
1818611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
0422-47-5511
skyoko@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin university school of medicine
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
0422-47-5511
Homepage URL
toshiaki_sato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin university school of medicine
Institute
Department
Personal name
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
Kyorin university, institutional review board
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
Tel
+81-422-47-5511
rec@ks.kyorin-u.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
| 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
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
| 2020 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036766
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
