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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031849
Receipt No. R000036259
Scientific Title Comparing Catheter Delivery System and Stylet Delivery System during implanting Ventricular Lead -A Randomized Trial-
Date of disclosure of the study information 2018/04/01
Last modified on 2020/03/24

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Basic information
Public title Comparing Catheter Delivery System and Stylet Delivery System during implanting Ventricular Lead -A Randomized Trial-
Acronym Comparing Catheter Delivery System and Stylet Delivery System during implanting Ventricular Lead
Scientific Title Comparing Catheter Delivery System and Stylet Delivery System during implanting Ventricular Lead -A Randomized Trial-
Scientific Title:Acronym Comparing Catheter Delivery System and Stylet Delivery System during implanting Ventricular Lead
Region
Japan

Condition
Condition Patients who need a pacemaker for atrioventricular block or bradycardia due to atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the safety and efficacy of catheter delivery system and stylet delivery system for positioning the ventricular pacemaker lead.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Attempt needed to implant the lead
Key secondary outcomes Time for lead implantation
Total radiation exposure dose for lead implantation
Need for change of implantation methods or change of physician to achieve lead implantation
Number of lead perforation
Number of lead dislodgment, need for re-positioning the 1 month after the implantation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Intervention duration:During lead implantation
Interventions/Control_2 Device:Comparing catheter delivery system and stylet delivery system
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who need a pacemaker implantation for atrio-ventricular block or bradycardia due to atrial fibrillation
Key exclusion criteria Patients who already have a medical device at the planned implantation site
Patients who were unsuitable for transvenous pacemaker implantation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kengo
Middle name
Last name Kusano
Organization National Cerebral and Cardiovascular Center
Division name Division of Cardiology
Zip code 5600081
Address 5-7-1, Fujishirodai, Suita City, Osaka, Japan
TEL 06-6833-5012
Email kusanokengo@gmail.com

Public contact
Name of contact person
1st name Kenichiro
Middle name
Last name Yamagata
Organization National Cerebral and Cardiovascular Center
Division name Division of Cardiology
Zip code 5600081
Address 5-7-1, Fujishirodai, Suita City, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email look.cardiology@gmail.com

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cerebral and Cardiovascular Center
Address 5-7-1, Fujishirodai, Suita City, Osaka, Japan
Tel +81668335012
Email rec-office-ac@ncvc.go.jp

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 国立循環器病研究センター

Other administrative information
Date of disclosure of the study information
2018 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 22 Day
Date of IRB
2018 Year 04 Month 17 Day
Anticipated trial start date
2018 Year 04 Month 18 Day
Last follow-up date
2020 Year 03 Month 24 Day
Date of closure to data entry
2020 Year 03 Month 24 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036259

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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