UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	DEFENSE Trial
Title of the study (Brief title)	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	Haruhiko Abe, MD
Organization	University of Occupational and Environmental Health,Japan
Division name	Department of Heart Rhythm Management
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	Ryusuke Kinoshita, Tomoyuki Yamaguchi
Organization	Medtronic Japan Co., Ltd.
Division name	CRDM
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000008332