UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056191 |
|---|---|
| Receipt number | R000063485 |
| Scientific Title | An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy. |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2026/01/07 07:30:21 |
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Basic information
Public title
An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy.
Acronym
An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy.
Scientific Title
An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy.
Scientific Title:Acronym
An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy.
Region
| Japan |
Condition
Condition
Atrioventricular block
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the efficacy and safety between novel method with contenuous pacing using a stylet-driven lead and intermittent pacing using a lumenless lead.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute procedure success: Percentage of patients achieving sucsessful left bandle branch area pacing.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention group: contenuous pacig method using a stylet-driven lead
Intervention duration: during pacemaker implantation
Number of interventions: once
Frequency: once
Interventions/Control_2
Control group: conventional method using a lumenless lead
Intervention duration: during pacemaker implantation
Number of interventions: once
Frequency: once
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are eligible for this study if they meet the following criteria.
1) Patients are older than 18 years.
2) Patients who required frequent ventricular pacing (>20%) due to bradyarrhythmia (atrioventricular block, bifascicular or trifascicular block, bradycardic atrial fibrillation).
Key exclusion criteria
1) Patients who are not expected to have a ventricular pacing burden of > 20%.
2) Patients who are eligible for an implantable cardioverter defibrillator (ICD) or a cardioverter defibrillator with biventricular pacing function (CRT-D).
3) Patients who have difficulty with transvenous lead placement.
4) Patients who are allergic to contrast.
5) Patinets who are pregnant or may become pregnant, or who are breast-feeding.
6) Patients who are considererd inappropriate by the principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yousaku |
| Middle name | |
| Last name | Ookubo |
Organization
Hiroshima University Hospital
Division name
Cardiology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5540
yokubo@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Maeda |
Organization
Hiroshima University Hospital
Division name
Cardiology
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
TEL
082-257-5540
Homepage URL
jun2.shiningcrystal@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Hiroshima University Hospital
Address
1-2-3 Kasumi, Minami-ku, Hiroshima City, Hiroshima Prefecture
Tel
082-257-5540
-
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
| 2024 | Year | 11 | Month | 19 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063485
