UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	FEAT-AT
Title of the study (Brief title)	FEAT-AT
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficiency of atrial Anti-Tachycardia Pacing (A-ATP) on atrial tachyarrhythmia (AT), and identify the factors that predict the A-ATP success.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A-ATP success rate on AT.
Key secondary outcomes	1) Prevalence of AT 2) Acceleration rate by A-ATP 3) Comparison of the prevalence of AT between patients with or without a history of AT. 4) Prevalence of AT in patients with pacemaker, ICD, or CRT.

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	1) Patients indicated with and implated pacemaker, ICD, or CRT equipped with A-ATP therapy function. 2) Patients who understand and sign the informed consent.
Key exclusion criteria	1) Patients who cannot be set the device with the required A-ATP programming. 2) Patients with permanent Af. 3) Patients who cannot visit the hospital according to the follow-up schedule or who cannot collect the data through the CareLink system. 4) Patients who are unwilling to provide written informed consent. 5) Patients who are not anticipated to complete this study. 6) Patients who are limited to participate this study due to his/her medical condition.
Target sample size	553

Research contact person
Name of lead principal investigator	Seiji Fukamizu
Organization	Tokyo Metropolitan Hiroo Hospital
Division name	Department of Cardiology
Address	2-34-10 Ebisu, Shibuya-ku, Tokyo, Japan
TEL	03-3444-1181
Email	nh6s-fkm@tc4.so-net.ne.jp

Public contact
Name of contact person	Masatsugu Okamoto
Organization	Medtronic Japan Co., Ltd.
Division name	Clinical Affairs
Address	1-2-70 Konan, Minato-ku, Tokyo, 108-0075, Japan
TEL	03-6776-0055
Homepage URL
Email	masatsugu.okamoto@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

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 06 Month 15 Day
Anticipated trial start date	2012 Year 08 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 08 Month 01 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010046