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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040622
Receipt No. R000046352
Scientific Title Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance
Date of disclosure of the study information 2020/06/02
Last modified on 2021/06/02

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Basic information
Public title Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance
Acronym Efficacy of physiological pacing
Scientific Title Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance
Scientific Title:Acronym Efficacy of physiological pacing
Region
Japan

Condition
Condition Bradycardia and/or conduction system disturbance
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and complication of the physiological His-Purkinje conduction system pacing
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Successful implantation of physiological His-Purkinje conduction system pacing lead and complications after implantation.
Key secondary outcomes 1) Predictors of successful or unsuccessful placement of the physiological pacing lead. 2) predictors of chronic excellent capture threshold, 3) efficacy for patients with infra-Hisian block, bundle branch block, or those with atrioventricular block after transcatheter aortic valve 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Permanent pacing indication class I and IIa for bradycardia or conduction system disturbance
Key exclusion criteria age of less than 20 years-old
Target sample size 240

Research contact person
Name of lead principal investigator
1st name Toshiaki
Middle name
Last name Sato
Organization Kyorin University,Medical school
Division name Division of Advanced Arrhythmia Management
Zip code 181-8611
Address 6-20-2 Shinkawa, Mitaka
TEL 0422-47-5511
Email toshiaki_sato@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name Toshiaki
Middle name
Last name Sato
Organization Kyorin University,Medical school
Division name Division of Advanced Arrhythmia Management
Zip code 181-8611
Address 6-20-2 Shinkawa, Mitaka
TEL +81-422-47-5511
Homepage URL
Email toshiaki_sato@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University
Institute
Department

Funding Source
Organization Kyorin University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Faculty of Medicine Research Ethics Committee, Kyorin University
Address 6-20-2 Shinkawa, Mitaka
Tel +81-422-47-5513
Email rec@ks.kyorin-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 杏林大学病院(東京都)
社会医療法人近森会近森病院 (高知県)
独立行政法人地域医療機能推進機構中京病院 (愛知県)
大阪市立総合医療センター (大阪府)
奈良県立医科大学病院 (奈良県)

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 02 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
2019 Year 10 Month 21 Day
Date of IRB
2021 Year 04 Month 22 Day
Anticipated trial start date
2021 Year 07 Month 22 Day
Last follow-up date
2024 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multi center observational study

Management information
Registered date
2020 Year 06 Month 02 Day
Last modified on
2021 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046352

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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