UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039647 |
|---|---|
| Receipt number | 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 | 2024/03/04 09:02:10 |
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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
1 All-cause death, heart failure hospitalization, upgrade to biventricular pacing
2 Reoperation, lead dislodgement, device infection
3 Relationship between LV-dp/dtmax and optimal AV delay
4 Echographic changes of LV strain, LVEF, and LVDd
5 Change in NT-proBNP
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
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/
masahiro-toba@doc.city.sapporo.jp
Sponsor or person
Institute
Sapporo City General Hospital
Institute
Department
Personal name
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
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
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | 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
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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