UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001307
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email info@hokujyun.or.jp

Sponsor
Institute Hokkaido Cardiovasucular Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001584

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.