UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The cross-over study of the usefulness of atrial antitachycardia pacing for atrial tachy-arrhythmia in patients implanted with cardiac devices
Title of the study (Brief title)	The comparison of the usefulness of atrial antitachycardia pacing in patients with cardiac devices
Region	Japan

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

Objectives
Narrative objectives1	To compare the efficacy of atrial anti- tachycardia pacing for atrial tachyarrhythmia in patients with cardiac devices Methods:Patients with device implantation equipped atrial anti-tachycardia pacing function (Medtronic: Advisa DR, Advisa MRI DR), implantable cardioverter defibrillator (ICD) (Medtronic: Virtuoso-Secura Protecta/Evera DR) or cardiac resynchronization therapy (CRT-D and CRT-P) (Medtronic: Target Concerto consultants protector Viva) will be included in this study. In patients with new device implantation, study entry would be later than one week after implantation. The ON and OFF of Atrial anti- tachycardia pacing will be crossovered for 6 months. Occurrence of primary and secondary outcome will be checked in the pacemaker clinic every 6 months.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of atrial fibrillation, efficacy of anti-tachycardia pacing at 6 month after intervention
Key secondary outcomes	Appropriate ICD/CRT-D therapy within two years after the registration (shock therapy and ATP therapy) In the case of CRT-P , the presence or absence of sustained ventricular tachycardia or ventricular fibrillation The presence or absence of inappropriate shock therapy Prognosis after implantation (death and cause, hospitalization for heart failure, unscheduled hospitalization )

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Devices equipped atrial anti-tachycardia pacing: pacemaker (Medtronic: Advisa DR, Advisa MRI DR), implantable cardioverter defibrillator (ICD) (Medtronic: Virtuoso-Secura Protecta · Evera DR) or cardiac resynchronization therapy (CRT-D and CRT-P) (Medtronic: Concerto Consulta Protecta Viva). Anti-tachycardia pacing therapy ON for 6 months->OFF for 6month
Interventions/Control_2	Devices equipped atrial anti-tachycardia pacing: pacemaker (Medtronic: Advisa DR, Advisa MRI DR), implantable cardioverter defibrillator (ICD) (Medtronic: Virtuoso-Secura Protecta · Evera DR) or cardiac resynchronization therapy (CRT-D and CRT-P) (Medtronic: Concerto Consulta Protecta Viva). Anti-tachycardia pacing therapy OFF for 6 months->ON for 6 months
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients implanted with Medtronic pacemaker or ICD implantation with atrial ATP function 2. Patients age 20 years of age or older , male and female 3. Implantation was based on JCS guildeline
Key exclusion criteria	1. Patients less than 20 years old 2. Patients who did not wish to participate in this study 3. Patients whom physician has determined the participation is difficult
Target sample size	100

Research contact person
Name of lead principal investigator	Seiji Takatsuki
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-5363-3928
Email	seiji.takatsuki@gmail.com

Public contact
Name of contact person	Yoshiyasu Aizawa
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-5363-3928
Homepage URL
Email	yoshiyaaizawa-circ@umin.ac.jp

Sponsor
Institute	Department of Cardiology Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of Cardiology Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 10 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 19 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

Management information
Registered date	2015 Year 10 Month 05 Day
Last modified on	2017 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022233