UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Electrophysiological Parameters related to His Bundle Pacing in Patients With Bradyarrhythmias
Acronym	His Bundle Pacing for Bradyarrhythmias
Scientific Title	Evaluation of Electrophysiological Parameters related to His Bundle Pacing in Patients With Bradyarrhythmias
Scientific Title:Acronym	His Bundle Pacing for Bradyarrhythmias
Region	Japan

Condition
Condition	Bradyarrhythmias
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify characteristics of electrophysiological parameters of optimal site for His bundle pacing
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Intracardiac potential and electrohysiological parameters recorded by His bundle pacing lead pre and post placement.
Key secondary outcomes	During 12 months after implant 1) Threshold and impedance of His bundle pacing 2) Amplitude of intracardiac potential 3) Complications related to His bundle pacing

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) pacemaker indication class I or class IIa; 2) intrinsic and minimum QRS duration of less than 150ms; 3) HBP lead implant guided by EP recording system
Key exclusion criteria	1) age of equal and more than 90 years-old and of less than 20 years-old; 2) left ventricular ejection fraction of less than 50%.
Target sample size	60

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

Sponsor
Institute	Kyorin University School of Medicine Division of Advanced Arrhythmia Management
Institute
Department

Funding Source
Organization	Kyorin University School of Medicine Division of Advanced Arrhythmia Management
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-City, Tokyo
Tel	+81-422-47-5511
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1016/j.jacep.2020.09.018
Number of participants that the trial has enrolled	50
Results	Overall, local ventricular thresholds were elevated during follow-up. The distal and proximal HBP thresholds did not differ. The local ventricular thresholds of distal HBP were significantly lower than those of proximal HBP. Optimal values of the ventricular measurements at implantation were determined for predicting the accepted ventricular threshold at 6 months. Distal HBP supported by stable local ventricular capture may be useful for treating pacing-dependent patients.
Results date posted	2020 Year 12 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 12 Month 24 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 12 Month 12 Day
Date of IRB	2017 Year 05 Month 29 Day
Anticipated trial start date	2016 Year 09 Month 27 Day
Last follow-up date	2021 Year 05 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Fifty patients with bradycardia (58% with atrioventricular block) underwent successful HBP and were followed for 1 year. Precise locations of the lead tips were confirmed using follow-up echocardiography.

Management information
Registered date	2018 Year 02 Month 19 Day
Last modified on	2020 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035808