UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Inappropriate implantable cardioverter-defibrillator therapy: Frequency, syncope and prognostic factors
Title of the study (Brief title)	Inappropriate ICD therapy survey
Region	Japan

Condition
Condition	Life-threatening arrhythmia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the incidence of syncope related to inappropriate ICD therapies.
Basic objectives2	Others
Basic objectives -Others	To clarify the prognostic factors in patients who had inappropriate ICD therapies.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of syncope related to inappropriate ICD therapies.
Key secondary outcomes	The prognostic factors in patients who had inappropriate ICD therapies.

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	To be enrolled, patients had to: (1) have an indication for ICD or CRT-D implantation according to the JCS Guidelines for Device-based Therapy of Cardiac Rhythm Abnormalities (2) be able to visit scheduled outpatient department and (3) be able to comply with the study protocol.
Key exclusion criteria	Patient exclusion criteria were no information on the medical condition, refused enrollment of this study.
Target sample size	200

Research contact person
Name of lead principal investigator	Eiichi Watanabe
Organization	Fujita Health University School of Medicine
Division name	Department of Cardiology
Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192
TEL	0562-93-2312
Email	enwatan@fujita-hu.ac.jp

Public contact
Name of contact person	Eiichi Watanabe
Organization	Fujita Health University School of Medicine
Division name	Department of Cardiology
Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192
TEL	0562-93-2312
Homepage URL
Email	enwatan@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Fujita Health University School of Medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 14 Day
Anticipated trial start date	2014 Year 10 Month 30 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	We examined 772 inappropriate ICD therapies occurring in 417 patients (age 61+/-15 years, primary prevention 65%). Patients experiencing an inappropriate therapy had a mean number of 1.8+/-1.5 therapy episodes during the mean follow-up period of 5.2 years. Only 3 patients (0.7%) experienced syncope associated with inappropriate therapies.

Management information
Registered date	2017 Year 02 Month 03 Day
Last modified on	2017 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029688