UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007377 |
|---|---|
| Receipt number | R000008690 |
| Scientific Title | Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up via Home Monitoring vs. Conventional In-office Follow-ups |
| Date of disclosure of the study information | 2012/02/24 |
| Last modified on | 2014/07/03 17:45:01 |
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Basic information
Public title
Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up via Home Monitoring vs. Conventional In-office Follow-ups
Acronym
atHome Study
Scientific Title
Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up via Home Monitoring vs. Conventional In-office Follow-ups
Scientific Title:Acronym
atHome Study
Region
| Japan |
Condition
Condition
Arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to demonstrate that the BIOTRONIK Home Monitoring system is able to reduce office follow-up visits without compromising patient safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The purpose of the primary endpoint is to compare the composite safety endpoint, Safety Event Rate (SER) which includes death, incidence of strokes and cardiovascular related serious adverse events requiring surgical interventions (e.g. device explants or lead revision) between the two groups. If the safety event rate for Group 1 is equivalent (non-inferior) to that of Group 2, patient follow-up by Home Monitoring is considered safe.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Remote monitoring only group (HM)
Interventions/Control_2
Remote monitoring + conventional in-office follow-up group
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Indicated for IPG implantation under Japanese guidelines
*Implanted with a BIOTRONIK IPG with Home Monitoring within the last 45 days, or being considered for implantation
*Able to utilize HM system throughout the study
*Ability to give informed consent
*Geographically stable and able to return for follow-ups for 27 months
*Over 20 years old
*Patient able to understand and follow the procedure stated in protocol
Key exclusion criteria
*Contraindicated for IPG under Japanese guidelines
*Patients who are currently included in another cardiac clinical study
*Patients with expected life period of less than 27 months
*Patients who might undergo heart transplantation in next 27 months.
Target sample size
1364
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Watanabe |
Organization
Fujita Health University
Division name
Cardiovascular Internal Medicine
Zip code
Address
1-98, Denrakuga-kubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL
0562932312
enwatan@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiko Ishiwatari |
Organization
Biotronik Japan
Division name
Cliniacl Affair
Zip code
Address
1-19-19 Ebisu, Shibuya-ku, Tokyo
TEL
03-3473-7478
Homepage URL
yoshiko.ishiwatari@biotronik.com
Sponsor or person
Institute
Biotronik Japan
Institute
Department
Personal name
Funding Source
Organization
Biotronik Japan
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01523704
Org. issuing International ID_1
Clinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 24 | Day |
Last modified on
| 2014 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008690
