UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005357 |
|---|---|
| Receipt number | R000006359 |
| Scientific Title | Clinical Evaluation of Percentage of Ventricular Pacing by SafeR Mode |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2015/07/08 11:52:48 |
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Basic information
Public title
Clinical Evaluation of Percentage of Ventricular Pacing by SafeR Mode
Acronym
SafeR Study
Scientific Title
Clinical Evaluation of Percentage of Ventricular Pacing by SafeR Mode
Scientific Title:Acronym
SafeR Study
Region
| Japan |
Condition
Condition
Patients with implanted pacemaker device
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether SafeR mode of Reply DR reduces percentage of ventricular pacing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To demonstrate that percentages of ventricular pacing significantly decrease during SafeR mode more than during DDD mode
Key secondary outcomes
-Number of times and operating duration of mode-switch by SafeR mode
-Number of times of PAC and PVC occurred during follow-up period
-Clinical observation and record during follow-up period (indication for implantation, underlying cardiac disease, preexisting arrhythmia, medical history and data of pacing leads at each follow-up, etc.)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients who meet the criterion of pacemaker implantation of the guideline for non-drug treatment for arrhythmia (revised in 2006) established by The Japan Circulation Society
-Patients those SafeR mode can be programmed
-Patients signed informed consent
Key exclusion criteria
-Patients who are not able to understand the purpose and protocol of the study
-Patients who are not able to come to the follow-up and those the investigator determines not eligible for the study
-Patients with any contraindication or/and who have possibility of being in the status of the warning stated in the package insert of the device
-Age of less than 20 years
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Shigeru Sakamoto |
Organization
Kanazawa Medical University Himi Municipal Hospital
Division name
Department of Cardiovascular Surgery
Zip code
Address
31-9, Saiwaicho, Himi-shi, Toyama, Japan
TEL
0766-74-1900
m-nomura@jll.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenjiro Hara |
Organization
Japan Lifeline Co., Ltd.
Division name
Cardiac Rhythm Management Division
Zip code
Address
25th Fl, NYK Tennoz Bldg. 2-2-20, Higashishinagawa, Shinagawa-ku, Tokyo, 140-0002, Japan
TEL
03-6711-5230
Homepage URL
m-nomura@jll.co.jp
Sponsor or person
Institute
Japan Lifeline Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Lifeline 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
金沢医科大学氷見市民病院（富山県）
社会保険紀南病院（和歌山県）
大阪府立成人病センター（大阪府）
岩国医療センター（山口県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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
Multi-center and prospective study
One week after implantation, set the pacemaker mode to DDD mode or to SafeR mode. At 1-month follow up, conduct device check, collect the data and fill in CRF. Change the mode to the another. At 2-month follow up, conduct device check, collect the data and fill in CRF.
Management information
Registered date
| 2011 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006359
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
