UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001458 |
|---|---|
| Receipt number | R000001769 |
| Scientific Title | Comparison of Automatic and Manual Threshold Testing |
| Date of disclosure of the study information | 2008/10/28 |
| Last modified on | 2010/10/22 14:23:40 |
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Basic information
Public title
Comparison of Automatic and Manual Threshold Testing
Acronym
COMET study
Scientific Title
Comparison of Automatic and Manual Threshold Testing
Scientific Title:Acronym
COMET study
Region
| Japan |
Condition
Condition
Patient implanted with cardiac pacemaker
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare time required to complete pacemaker follow-up with/without using automatic features in Medtronic cardiac pacemakers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to complete device follow-up.
Key secondary outcomes
Measured pacing threshold.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient who has implanted with Medtronic cardiac pacemaker (Adapta or Sensia).
2) Patient who signed informed consent.
Key exclusion criteria
1) Patient who is not abpe to program device automatic features (i.e., ACM, VCM or Sensing Assurance).
2) Patient who is not able to visit clinic according to scheduled follow-up.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Tsunoda |
Organization
Medtronic Japan Co., Ltd.
Division name
CRDM Clinical
Zip code
Address
Comodio Shiodome 5F, 2-14-1 Higashi-Simbashi, Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Medtronic Japan Co., Ltd.
Division name
CRDM Clinical
Zip code
Address
Comodio Shiodome 5F, 2-14-1 Higashi-Simbashi, Minato-ku, Tokyo
TEL
03-6430-7023
Homepage URL
Sponsor or person
Institute
Medtronic Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan 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
Address
Tel
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
| 2008 | Year | 10 | Month | 28 | 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
Completed
Date of protocol fixation
| 2008 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Record time required to complete pacemaker follow-up, pacing threshold, amplitudes of P-wave and R-wave measured during follow-up.
Management information
Registered date
| 2008 | Year | 10 | Month | 28 | Day |
Last modified on
| 2010 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001769
