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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007212
Receipt No. R000008332
Scientific Title DEFENSE Trial
Date of disclosure of the study information 2012/02/02
Last modified on 2016/08/08

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Basic information
Public title DEFENSE Trial
Acronym DEFENSE Trial
Scientific Title DEFENSE Trial
Scientific Title:Acronym DEFENSE Trial
Region
Japan

Condition
Condition Subjects indicated for ICD or CRT-D.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficiency of a new algorithm of Medtroinic ICD/CRT-D for ICD shock reduction, SmartShock Technology (SST) .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ICD shock reduction rate with a new algorithm of Medtronic ICD/CRT-D, SST.
Key secondary outcomes ICD shock rate and the cause of inappropriate shocks.

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 i, ICD or CRT-D patients who receive newly or replace to the device equipped with SST.
ii, Patients who understand and sign the informed consent.
Key exclusion criteria i, Patients who cannot visit the hospital according to the follow-up schedule or who cannot collect the data through the CareLink system.
ii, Patients who are unwilling to provide written informed consent.
iii, Patients who are anticipated not to be able to set the device with required programming
iv, Patients who are not expected to survive more than 6 months.
Target sample size 151

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Abe, MD
Organization University of Occupational and Environmental Health,Japan
Division name Department of Heart Rhythm Management
Zip code
Address 1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, Japan
TEL 093-603-1611
Email haru-abe@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryusuke Kinoshita, Tomoyuki Yamaguchi
Organization Medtronic Japan Co., Ltd.
Division name CRDM
Zip code
Address 3-8-1 Asano Kokurakita-ku Kitakyushu-city, Fukuoka, Japan
TEL 093-512-4666
Homepage URL
Email ryusuke.kinoshita@medtronic.com

Sponsor
Institute Medtronic Japan Co., Ltd
Institute
Department

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
Email

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 産業医科大学(福岡県)他

Other administrative information
Date of disclosure of the study information
2012 Year 02 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
2012 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective, observational trial

Management information
Registered date
2012 Year 02 Month 02 Day
Last modified on
2016 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008332

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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