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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005357
Receipt No. 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

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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
Email 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
Email m-nomura@jll.co.jp

Sponsor
Institute Japan Lifeline Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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