UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043493 |
|---|---|
| Receipt number | R000049668 |
| Scientific Title | Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure |
| Date of disclosure of the study information | 2021/03/04 |
| Last modified on | 2021/03/02 12:43:38 |
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Basic information
Public title
Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure
Acronym
Efficacy of physiological left bundle branch area pacing
Scientific Title
Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure
Scientific Title:Acronym
Efficacy of physiological left bundle branch area pacing
Region
| Japan |
Condition
Condition
To investigate the efficacy and complication of the physiological left bundle branch area pacing
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and complication of the physiological left bundle branch area pacing
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful implantation of physiological left bundle branch area pacing lead and complications during more than six months
Key secondary outcomes
1)Comparison of electrical propagation in the conduction system and ventricle between the His-bundle pacing and left bundle branch area pacing. 2) Identification of predictors for successful implantation of left bundle branch area pacing lead. 3) Cardiac function during left bundle branch area pacing.
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
1) Permanent pacing indication class I and IIa for bradycardia or conduction system disturbance.
2) Cardiac resynchronization therapy indication class IIa in patients with atrioventricular block, left ventricular ejection fraction of 36-50% and pacing dependency.
3) Cardiac resynchronization therapy indication class I- IIa in patients with left ventricular ejection fraction of <36% and failure of left ventricle pacing and non-responder for cardiac resynchronization therapy
Key exclusion criteria
age of less than 20 years-old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University,Medical school
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
0422-47-5511
toshiaki_sato@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University,Medical school
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka
TEL
0422-47-5511
Homepage URL
toshiaki_sato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
Tel
+81-422-47-5513
rec@ks.kyorin-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center observational study
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049668
