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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035534
Receipt No. R000040484
Scientific Title Long-term prognosis and assessment of electrical conduction system in patients with his-bundle pacemaker in a multicenter study
Date of disclosure of the study information 2019/04/01
Last modified on 2019/07/15

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Basic information
Public title Long-term prognosis and assessment of electrical conduction system in patients with his-bundle pacemaker in a multicenter study
Acronym His-bundle pacemaker in a multicenter study
Scientific Title Long-term prognosis and assessment of electrical conduction system in patients with his-bundle pacemaker in a multicenter study
Scientific Title:Acronym His-bundle pacemaker in a multicenter study
Region
Japan

Condition
Condition Atrioventricular block or conduction delay requiring pacemaker implantation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Long-term prognosis and safety after implantation of His-bundle pacemaker
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death, hospitalization due to heart failure, and upgrading to cardiac resynchronization therapy device
Key secondary outcomes Changes in cardiac function, and laboratory data 6-12 months after implantation

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Prospective cohort
Patients scheduled for and with a history of His-bundle pacemaker implantation
-Atrioventricular block or complete bundle branch block
-Estimated ventricular pacing more than 40%
-Obtained an agreement for study inclusion

Retrospective cohort
Patients with a history of His-bundle pacemaker implantation
Fulfill the similar inclusion criteria of the prospective cohort as above.
Key exclusion criteria Patients request for decline study inclusion
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Toyoaki
Middle name
Last name Murohara
Organization Nagoya University Graduate School of Medicine
Division name Department of Cardiology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi4668550, Japan.
TEL 81-52-744-2147
Email murohara@med.nagoya-u.ac.jp.

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Yanagisawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Advanced Cardiovascular Therapeutics
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi4668550, Japan.
TEL 81-52-744-2147
Homepage URL
Email yanagisawa-sato@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Cardiology
Institute
Department

Funding Source
Organization Medtronic, Japan.
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 The Nagoya University Ethics Committee
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi4668550, Japan.
Tel 81-52-744-2423
Email ethics@med.nagoya-u.ac.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 名古屋大学医学部附属病院(愛知県)、JCHO 中京病院(愛知県)、名古屋第二赤十字病院(愛知県)、大垣市民病院(岐阜県)、安城更生病院(愛知県)、小牧市民病院(愛知県)、豊田厚生病院(愛知県)、トヨタ記念病院(愛知県)

Other administrative information
Date of disclosure of the study information
2019 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 13 Day
Date of IRB
2019 Year 03 Month 19 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2019 Year 01 Month 13 Day
Last modified on
2019 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040484

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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