UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010701 |
|---|---|
| Receipt number | R000011872 |
| Scientific Title | Comparison of the effectiveness of atrial antitachycardia pacing on reduction of atrial tachycardia burden by atrial lead position, atrial appendage or atrial septum. (SAFETY Trial) |
| Date of disclosure of the study information | 2013/05/13 |
| Last modified on | 2017/12/06 09:30:00 |
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Basic information
Public title
Comparison of the effectiveness of atrial antitachycardia pacing on reduction of atrial tachycardia burden by atrial lead position, atrial appendage or atrial septum. (SAFETY Trial)
Acronym
SAFETY Trial
Scientific Title
Comparison of the effectiveness of atrial antitachycardia pacing on reduction of atrial tachycardia burden by atrial lead position, atrial appendage or atrial septum. (SAFETY Trial)
Scientific Title:Acronym
SAFETY Trial
Region
| Japan |
Condition
Condition
Atrial Tachyarrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of atrial antitachycardia pacing on reduction of atrial tachycardia burden by atrial lead position, atrial appendage or atrial septum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AT/AF burden
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Atrial lead position (Appendage)
Interventions/Control_2
Atrial lead position (Septum)
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 who have been documented atrial tachyarrhythmia on ECG or holter ECG.
2) Patients who will be implanted a pacemaker, ICD, CRT-P, or CRT-D with A-ATP function.
3) Patients willing to sign and submit a consent form.
Key exclusion criteria
1) Patients who have AV block and are not expected to program to AAI mode. (except CRT-P/D patients)
2) Patients who have advanced AV block.
3) Patients who have permanent atrial fibrillation.
4) Patients anticipated not being able to comply with the follow-up schedule.
5) Patients unwilling to provide written consent form.
6) Patients anticipated not being able to complete the study
Target sample size
422
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
University of Tsukuba
Division name
Cardiovascular Division
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3143
tkbcar@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatsugu Okamoto |
Organization
Medtronic Japan
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
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan
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
| 2013 | Year | 05 | Month | 13 | 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
| 2013 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 13 | Day |
Last modified on
| 2017 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011872
