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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039647
Receipt No. R000045219
Scientific Title Prospective evaluation of efficacy of left bundle branch pacing in patients with bradycardia
Date of disclosure of the study information 2020/05/01
Last modified on 2020/05/02

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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 Relation 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
2020 Year 05 Month 02 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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