UMIN-CTR Clinical Trial

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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