UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019239
Receipt No. R000022233
Scientific Title The cross-over study of the usefulness of atrial antitachycardia pacing for atrial tachy-arrhythmia in patients implanted with cardiac devices
Date of disclosure of the study information 2015/10/05
Last modified on 2017/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The cross-over study of the usefulness of atrial antitachycardia pacing for atrial tachy-arrhythmia in patients implanted with cardiac devices
Acronym The comparison of the usefulness of atrial antitachycardia pacing in patients with cardiac devices
Scientific Title The cross-over study of the usefulness of atrial antitachycardia pacing for atrial tachy-arrhythmia in patients implanted with cardiac devices
Scientific Title:Acronym 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
1st name
Middle name
Last name Seiji Takatsuki
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-5363-3928
Email seiji.takatsuki@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyasu Aizawa
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000022233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.