UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040622 |
|---|---|
| Receipt number | R000046352 |
| Scientific Title | Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance |
| Date of disclosure of the study information | 2020/06/02 |
| Last modified on | 2021/06/02 11:43:31 |
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Basic information
Public title
Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance
Acronym
Efficacy of physiological pacing
Scientific Title
Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance
Scientific Title:Acronym
Efficacy of physiological pacing
Region
| Japan |
Condition
Condition
Bradycardia and/or conduction system disturbance
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and complication of the physiological His-Purkinje conduction system pacing
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Successful implantation of physiological His-Purkinje conduction system pacing lead and complications after implantation.
Key secondary outcomes
1) Predictors of successful or unsuccessful placement of the physiological pacing lead. 2) predictors of chronic excellent capture threshold, 3) efficacy for patients with infra-Hisian block, bundle branch block, or those with atrioventricular block after transcatheter aortic valve implantation
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
Permanent pacing indication class I and IIa for bradycardia or conduction system disturbance
Key exclusion criteria
age of less than 20 years-old
Target sample size
240
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
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
+81-422-47-5511
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
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
杏林大学病院(東京都)
社会医療法人近森会近森病院 (高知県)
独立行政法人地域医療機能推進機構中京病院 (愛知県)
大阪市立総合医療センター (大阪府)
奈良県立医科大学病院 (奈良県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 02 | 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 | 10 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi center observational study
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046352
