UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053252 |
|---|---|
| Receipt number | R000060772 |
| Scientific Title | Outcomes of Left Bundle Branch Area Pacing Compared with His Bundle Pacing and Right Ventricular Apical Pacing |
| Date of disclosure of the study information | 2023/12/30 |
| Last modified on | 2023/12/30 21:11:12 |
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Basic information
Public title
Outcomes of Left Bundle Branch Area Pacing Compared with His Bundle Pacing and Right Ventricular Apical Pacing
Acronym
Outcomes of Left Bundle Branch Area Pacing Compared with His Bundle Pacing and Right Ventricular Apical Pacing
Scientific Title
Outcomes of Left Bundle Branch Area Pacing Compared with His Bundle Pacing and Right Ventricular Apical Pacing
Scientific Title:Acronym
Outcomes of Left Bundle Branch Area Pacing Compared with His Bundle Pacing and Right Ventricular Apical Pacing
Region
| Japan |
Condition
Condition
bradycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to compare the clinical outcomes of left bundle branch area pacing, His bundle pacing, and right ventricular apical pacing in Japanese patients with bradycardia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary study endpoint was the cumulative incidence of heart failure hospitalization during the follow-up.
Key secondary outcomes
The secondary endpoints included (1) all-cause death, (2) cardiac death, (3) a need for biventricular pacing (BVP) upgrade; and (4) major cardiovascular events (MACE; a composite of all-cause death, heart failure hospitalization, and a need for BVP upgrade).
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were 20 years or older underwent lead-type pacemaker implantation for bradycardia.
Key exclusion criteria
Right ventricular septum pacing, leadless pacemaker implantation, implantable cardioverter defibrillator implantation, or cardiac resynchronization therapy were excluded.
Target sample size
424
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ando |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
8028555
Address
3-2-1, Asano, Kokurakita Ward, Kitakyushu, Fukuoka
TEL
0935112000
kenji-ando@live.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kono |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
8028555
Address
3-2-1, Asano, Kokurakita Ward, Kitakyushu, Fukuoka
TEL
0935112000
Homepage URL
kouno-hr@kokurakinen.or.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokura Memorial Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kokura Memorial Hospital
Address
3-2-1, Asano, Kokurakita Ward, Kitakyushu, Fukuoka
Tel
0935112000
rinshyo@kokurakinen.or.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
小倉記念病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 30 | 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
424
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective, observational study.
Management information
Registered date
| 2023 | Year | 12 | Month | 30 | Day |
Last modified on
| 2023 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060772
