UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027508 |
|---|---|
| Receipt number | R000031514 |
| Scientific Title | efficacy OF high FrequENcy atrial anti-tachy paCing in nEw algorithm for atrial arrhythmia trial at Kokura Memorial Hospital Trial |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2023/12/01 09:10:31 |
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Basic information
Public title
efficacy OF high FrequENcy atrial anti-tachy paCing in nEw algorithm for atrial arrhythmia trial at Kokura Memorial Hospital Trial
Acronym
OFFENCE trial
Scientific Title
efficacy OF high FrequENcy atrial anti-tachy paCing in nEw algorithm for atrial arrhythmia trial at Kokura Memorial Hospital Trial
Scientific Title:Acronym
OFFENCE trial
Region
| Japan |
Condition
Condition
atrial tachyarrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study is to evaluate the efficacy of of atrial antitachycardia pacing (aATP) therapies in comparison with previous frequency, for patients with dual-chamber Medtronic pacemaker, implantable cardioverter defibrillator with or without cardiac resynchronization therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The longest single episode of subclinical atrial fibrillation
Key secondary outcomes
1) Cumulative percentage of progression of atrial tachyarrhythmias to permanent atrial fibrillation
2) Atrial fibrillation/atrial tachycardia burden (hour/day)
3) Cumulative percentage of terminating atrial tachyarrhythmias with aATP
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Activation of atrial antitachycardia pacing (aATP) therapies
Detection and frequency of aATP therapies
･ Time Interval every 2 hours
･ Episode duration before Rx delivery 1 minute
･ Duration to stop 48 hours
Detailed aATP setting
･ Rx1 Ramp (8 sequences) A-S1 interval 91%
･ Rx2 Burst+ (6 sequences) A-S1 interval 91% S1-S2 interval 84%
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with a Medtronic dual chamber implantable pulse generator with aATP (Advisa DR, Syncra CRTP, Protecta XT ICD, Protecta XT CRTD), at least 3 months after implantation.
2) Patients 20 years or older.
3) Patients possible to follow up in Kokura Memorial Hospital
4) Patients with written informed consent.
Key exclusion criteria
1) Patients with long standing persistent atrial fibrillation.
2) Patients with expectation of survival less than one year.
Target sample size
657
Research contact person
Name of lead principal investigator
| 1st name | Ando |
| Middle name | |
| Last name | Kenji |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1, Asano, Kokurakita-ku Kitakyushu, Fukuoka, Japan
TEL
+81-93-511-2000
kmhptca@kokura-heart.com
Public contact
Name of contact person
| 1st name | Fukunaga |
| Middle name | |
| Last name | Masato |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
802-8555
Address
3-2-1, Asano, Kokurakita-ku Kitakyushu, Fukuoka, Japan
TEL
+81-93-511-2000
Homepage URL
masato_f0728@yahoo.co.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Kokura Memorial Hospital
Address
3-2-1, Asano, Kokurakita-ku Kitakyushu, Fukuoka, Japan
Tel
0935112000
kmhptca@kokura-heart.com
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
平成紫川会 小倉記念病院 循環器内科
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 29 | 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
541
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under analysis
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031514
| Research Plan | |
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