UMIN-CTR Clinical Trial

Basic information
Public title	Coordinated strain and Response of Contraction by Left Bundle Branch Pacing Study
Acronym	CORRECT-LBB Study
Scientific Title	Prospective evaluation of efficacy of left bundle branch pacing in patients with bradycardia
Scientific Title:Acronym	CORRECT-LBB Study
Region	Japan

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

Objectives
Narrative objectives1	This study is aimed to identify the patients who benefit most from left bundle branch pacing.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in maximum rate of left ventricular pressure (LV-dP/dtmax) and 2D-speckle tracking strain of left ventricle by left bundle branch pacing
Key secondary outcomes

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	Among patients referred to Sapporo City General Hospital for permanent pacemaker implantation due to bradycardia, (1) those with a LVEF greater than 35% and left bundle branch block, (2) those with failure of His bundle pacing, are eligible. (3) Patients undergoing implantation of a cardiac resynchronization therapy (CRT) device, with lack of appropriate coronary sinus vein for a LV lead placement, are also eligible.
Key exclusion criteria	Patients who are judged as inappropriate for the study by investigators are excluded.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Yokoshiki
Organization	Sapporo City General Hospital
Division name	Cardiovascular Medicine
Zip code	060-8604
Address	Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan
TEL	011-726-2211
Email	hisashi.yokoshiki@doc.city.sapporo.jp

Public contact
Name of contact person	1st name Toba Middle name Last name Masahiro
Organization	Sapporo City General Hospital
Division name	Cardiovascular Medicine
Zip code	060-8604
Address	Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan
TEL	011-726-2211
Homepage URL	https://www.city.sapporo.jp/hospital/
Email	masahiro-toba@doc.city.sapporo.jp

Sponsor
Institute	Sapporo City General Hospital
Institute
Department

Funding Source
Organization	None
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	Sapporo City General Hospital Research Ethics Committee
Address	Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan
Tel	011-726-2211
Email	ryota.hayashi@city.sapporo.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	市立札幌病院　Sapporo City General Hospital

Other administrative information
Date of disclosure of the study information	2020 Year 05 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	Open public recruiting
Date of protocol fixation	2020 Year 02 Month 20 Day
Date of IRB	2020 Year 02 Month 27 Day
Anticipated trial start date	2020 Year 03 Month 23 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 12 Month 31 Day
Date analysis concluded	2024 Year 01 Month 31 Day

Other
Other related information	Relationship between optimal LV strain by left bundle branch pacing and electrocardiographic findings

Management information
Registered date	2020 Year 02 Month 29 Day
Last modified on	2021 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045219

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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