UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001307 |
|---|---|
| Receipt number | R000001584 |
| Scientific Title | A Prospective Randomized Comparison of Permanent Septal versus Apical Right Ventricular Pacing |
| Date of disclosure of the study information | 2008/08/08 |
| Last modified on | 2009/03/13 17:52:04 |
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Basic information
Public title
A Prospective Randomized Comparison of Permanent Septal versus Apical Right Ventricular Pacing
Acronym
A Prospective Randomized Comparison of Permanent Septal versus Apical Right Ventricular Pacing
Scientific Title
A Prospective Randomized Comparison of Permanent Septal versus Apical Right Ventricular Pacing
Scientific Title:Acronym
A Prospective Randomized Comparison of Permanent Septal versus Apical Right Ventricular Pacing
Region
| Japan |
Condition
Condition
Sick sinus syndrome
Atrial fibrillation with bradycardia
Advanced AV block
Complete AV block
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate differences of clinical effect and safety between Right ventricular septal pacing and Right ventricular apical pacing
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Left ventricular ejection fraction,
BNP,
Key secondary outcomes
admission due to major adverse cardiac event,
heart failure,
pacing failure,
Percent Fractional shortening,
Left atrial diameter,
Left ventricular systolic diameter,
Left ventricular diastolic diameter,
Tricuspid valve regurgitation,
Mitral valve regurgitation,
QRS width,
QRS axis,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Right ventricular septal pacing
Interventions/Control_2
Right ventricular apical pacing
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 have a indication of permanent pace making instrument implantation
Key exclusion criteria
Patients who have been taken a operation of permanent pace making instrument implantation
Patients who suffer from a severe disease with poor prognosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasutaka Hirayama |
Organization
Hokkaido Cardiovasucular Hospital
Division name
Division of Cardiology
Zip code
Address
1-30 South27 West13 Chuo-ku Sapporo Japan
TEL
011-563-3911
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutaka Hirayama |
Organization
Hokkaido Cardiovasucular Hospital
Division name
Division of Cardiology
Zip code
Address
1-30 South27 West13 Chuo-ku Sapporo Japan
TEL
011-563-3911
Homepage URL
info@hokujyun.or.jp
Sponsor or person
Institute
Hokkaido Cardiovasucular Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
Department of Health Science, Asahikawa Medical College
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
| 2008 | Year | 08 | Month | 08 | 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
Date of protocol fixation
| 2008 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 08 | Day |
Last modified on
| 2009 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001584
| Research Plan | |
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| 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 |
