UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the effectiveness of atrial antitachycardia pacing on reduction of atrial tachycardia burden by atrial lead position, atrial appendage or atrial septum. (SAFETY Trial)
Title of the study (Brief title)	SAFETY Trial
Region	Japan

Condition
Condition	Atrial Tachyarrhythmia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of atrial antitachycardia pacing on reduction of atrial tachycardia burden by atrial lead position, atrial appendage or atrial septum.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AT/AF burden
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Atrial lead position (Appendage)
Interventions/Control_2	Atrial lead position (Septum)
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 who have been documented atrial tachyarrhythmia on ECG or holter ECG. 2) Patients who will be implanted a pacemaker, ICD, CRT-P, or CRT-D with A-ATP function. 3) Patients willing to sign and submit a consent form.
Key exclusion criteria	1) Patients who have AV block and are not expected to program to AAI mode. (except CRT-P/D patients) 2) Patients who have advanced AV block. 3) Patients who have permanent atrial fibrillation. 4) Patients anticipated not being able to comply with the follow-up schedule. 5) Patients unwilling to provide written consent form. 6) Patients anticipated not being able to complete the study
Target sample size	422

Research contact person
Name of lead principal investigator	Kazutaka Aonuma
Organization	University of Tsukuba
Division name	Cardiovascular Division
Address	2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL	029-853-3143
Email	tkbcar@md.tsukuba.ac.jp

Public contact
Name of contact person	Masatsugu Okamoto
Organization	Medtronic Japan
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
Institute
Department

Funding Source
Organization	Medtronic Japan
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	2013 Year 05 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 15 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2018 Year 11 Month 15 Day
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

Management information
Registered date	2013 Year 05 Month 13 Day
Last modified on	2017 Year 12 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011872