UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019459 |
|---|---|
| Receipt number | R000019809 |
| Scientific Title | Assess the EFfects of RAte ReSponse AlgoriThm on the prEvention of AtRial Fibrillation |
| Date of disclosure of the study information | 2015/10/22 |
| Last modified on | 2015/10/23 14:10:34 |
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Basic information
Public title
Assess the EFfects of RAte ReSponse AlgoriThm on the prEvention of AtRial Fibrillation
Acronym
FASTER Study
Scientific Title
Assess the EFfects of RAte ReSponse AlgoriThm on the prEvention of AtRial Fibrillation
Scientific Title:Acronym
FASTER Study
Region
| Japan |
Condition
Condition
Sick sinus syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effcts of rate response algorithm on AF burden in pacemaker patients with sick sinus syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total AF burden during 6 months
Key secondary outcomes
Changes of total AF burden, a day averaged AF burden and (atrial- and ventricular)pacing ratio
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rate Response ON during first 6 months
Rate Response OFF during next 6 months
Interventions/Control_2
Rate Response OFF during first 6 months
Rate Response ON during next 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
dual chamber pacemaker patients with sick sinus syndrome
more than 20 years old
willing and capble of providing informed consent
Key exclusion criteria
central nerve system, liver and /or kidny diseases
chronic AF
Complete and advanced AV block
surgical and/or catheter ablation within recent 3 months
pregnancy or plan to become pregnant
all patient who are inappropreate for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Ogawa |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
ogawam@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaoru Hosoi Kaori Urabe |
Organization
Fukuoka University School of Medicine
Division name
Department of Cardiology
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
junkan3@minf.med.fukuoka-u.ac.jp
Sponsor or person
Institute
Department of CardiologyFukuoka University School of medicine
Institute
Department
Personal name
Funding Source
Organization
NPO Clinical and Applied Science, Fukuoka
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yamaguchi University Hospital
Kameda Medical Center
Yokohama Rosai Hospital
Tokuyama Chuo Hospital
Fukuseikai Hospital
Makiyama Chuo Hospital
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
福岡大学病院 Fukuoka University Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | 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 | 22 | Day |
Last modified on
| 2015 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019809
