UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008593 |
|---|---|
| Receipt number | R000010046 |
| Scientific Title | FEAT-AT |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2017/11/02 14:32:13 |
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Basic information
Public title
FEAT-AT
Acronym
FEAT-AT
Scientific Title
FEAT-AT
Scientific Title:Acronym
FEAT-AT
Region
| Japan |
Condition
Condition
Subjects indicated for pacemaker, ICD, or CRT.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficiency of atrial Anti-Tachycardia Pacing (A-ATP) on atrial tachyarrhythmia (AT), and identify the factors that predict the A-ATP success.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A-ATP success rate on AT.
Key secondary outcomes
1) Prevalence of AT
2) Acceleration rate by A-ATP
3) Comparison of the prevalence of AT between patients with or without a history of AT.
4) Prevalence of AT in patients with pacemaker, ICD, or CRT.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients indicated with and implated pacemaker, ICD, or CRT equipped with A-ATP therapy function.
2) Patients who understand and sign the
informed consent.
Key exclusion criteria
1) Patients who cannot be set the device with the required A-ATP programming.
2) Patients with permanent Af.
3) Patients who cannot visit the hospital according to the follow-up schedule or who cannot collect the data through the CareLink system.
4) Patients who are unwilling to provide
written informed consent.
5) Patients who are not anticipated to complete this study.
6) Patients who are limited to participate this study due to his/her medical condition.
Target sample size
553
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Fukamizu |
Organization
Tokyo Metropolitan Hiroo Hospital
Division name
Department of Cardiology
Zip code
Address
2-34-10 Ebisu, Shibuya-ku, Tokyo, Japan
TEL
03-3444-1181
nh6s-fkm@tc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatsugu Okamoto |
Organization
Medtronic Japan Co., Ltd.
Division name
Clinical Affairs
Zip code
Address
1-2-70 Konan, Minato-ku, Tokyo, 108-0075, Japan
TEL
03-6776-0055
Homepage URL
masatsugu.okamoto@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, observational trial
Management information
Registered date
| 2012 | Year | 08 | Month | 01 | Day |
Last modified on
| 2017 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010046
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
