UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003442 |
|---|---|
| Receipt number | R000004073 |
| Scientific Title | Evaluation of Defibrillation SAfety with the Increased Number of Sensing to Reduce ShocKS for Ventricular Tachyarrhythmia in Japanese ICD Patients |
| Date of disclosure of the study information | 2010/04/02 |
| Last modified on | 2012/07/27 09:28:54 |
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Basic information
Public title
Evaluation of Defibrillation SAfety with the Increased Number of Sensing to Reduce ShocKS for Ventricular Tachyarrhythmia
in Japanese ICD Patients
Acronym
SANKS study
Scientific Title
Evaluation of Defibrillation SAfety with the Increased Number of Sensing to Reduce ShocKS for Ventricular Tachyarrhythmia
in Japanese ICD Patients
Scientific Title:Acronym
SANKS study
Region
| Japan |
Condition
Condition
ICD or CRT-D cases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To evaluate non-inferiority of VT/VF termination rate with NID:30/40 to 18/24
2) To evaluate the efficacy of prolonged NID on the inappropriate shock reduction by analyzing retrospective EGM data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a, VF termination rate by ICD shock therapy in VF induction test.
b, Inappropriate shock reduction rate by simutating NID as 30/40.
Key secondary outcomes
Time from VF induction and detection to VF termination.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
VT/VF detection parameter: 18/24
Interventions/Control_2
VT/VF detection parameter: 30/40
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) ICD/CRT-D patients
2) Patients whoes clinical condition are stable.
3) Patients who are able to receive VF induction tests.
4) Patients who are able to conduct VF induction tests with 25J.
5) Patients who sign the informed consents.
Key exclusion criteria
1) Patients whoes clinical condition are not acceptable to VF induction tests.
2) Patients who are limited to participate this study due to their clinical condition.
3) Patients who can not sign the informed consents.
Target sample size
186
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Tejima |
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
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
| 2009 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 02 | Day |
Last modified on
| 2012 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004073
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
