UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035534 |
|---|---|
| Receipt number | 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 | 2022/07/17 10:21:56 |
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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
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
yanagisawa-sato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Cardiology
Institute
Department
Personal name
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
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
No longer 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
| 2022 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040484
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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