UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure
Acronym	Efficacy of physiological left bundle branch area pacing
Scientific Title	Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure
Scientific Title:Acronym	Efficacy of physiological left bundle branch area pacing
Region	Japan

Condition
Condition	To investigate the efficacy and complication of the physiological left bundle branch area pacing
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and complication of the physiological left bundle branch area pacing
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Successful implantation of physiological left bundle branch area pacing lead and complications during more than six months
Key secondary outcomes	1)Comparison of electrical propagation in the conduction system and ventricle between the His-bundle pacing and left bundle branch area pacing. 2) Identification of predictors for successful implantation of left bundle branch area pacing lead. 3) Cardiac function during left bundle branch area 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Permanent pacing indication class I and IIa for bradycardia or conduction system disturbance. 2) Cardiac resynchronization therapy indication class IIa in patients with atrioventricular block, left ventricular ejection fraction of 36-50% and pacing dependency. 3) Cardiac resynchronization therapy indication class I- IIa in patients with left ventricular ejection fraction of <36% and failure of left ventricle pacing and non-responder for cardiac resynchronization therapy
Key exclusion criteria	age of less than 20 years-old
Target sample size	100

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-City, Tokyo
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	0422-47-5511
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-City, Tokyo
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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 04 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 11 Month 01 Day
Date of IRB	2019 Year 11 Month 01 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2024 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Single center observational study

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2021 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049668