UMIN-CTR Clinical Trial

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
Email	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
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	Kyorin university, institutional review board
Address	6-20-2 Shinkawa, Mitaka-City, Tokyo
Tel	+81-422-47-5511
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036766