UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003441 |
|---|---|
| Receipt number | R000004062 |
| Scientific Title | Evaluation of the efficacy of ICD inappropriate shock reduction -Virtual ICD- |
| Date of disclosure of the study information | 2010/04/02 |
| Last modified on | 2011/09/28 10:01:31 |
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Basic information
Public title
Evaluation of the efficacy of ICD inappropriate shock reduction -Virtual ICD-
Acronym
Virtual ICD Japan
Scientific Title
Evaluation of the efficacy of ICD inappropriate shock reduction -Virtual ICD-
Scientific Title:Acronym
Virtual ICD Japan
Region
| Japan |
Condition
Condition
ICD or CRT-D cases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of a new detection algorithm for inappropriate shock reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Efficacy of a new detection algorithm for inappropriate shock reduction.
2) Sensitivity, specificity and positive predictive value of ICD shock therapy by a new detection algorithm.
Key secondary outcomes
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
a. Patients who have implanted a Medtronic ICD or CRT-D.
b. Patients whose EGM data have been kept.
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Tsunoda |
Organization
Medtronic Japan Co., Ltd.
Division name
CRDM
Zip code
Address
Comodio Shiodome 5F, 2-14-1 Higashi Shimbashi, Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Tejima |
Organization
Medtronic Japan Co., Ltd.
Division name
CRDM
Zip code
Address
TEL
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 02 | 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
| 2010 | Year | 01 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Open the information of this study after the approval of Medical Ethics Committee to the patients to give the opportunity to disclaim their participation.
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2011 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004062
