UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019239 |
|---|---|
| Receipt number | 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 11:14:57 |
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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
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
yoshiyaaizawa-circ@umin.ac.jp
Sponsor or person
Institute
Department of Cardiology
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022233
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