UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031364 |
|---|---|
| Receipt number | R000035808 |
| Scientific Title | Evaluation of Electrophysiological Parameters related to His Bundle Pacing in Patients With Bradyarrhythmias |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2020/12/25 15:02:50 |
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Basic information
Public title
Evaluation of Electrophysiological Parameters related to His Bundle Pacing in Patients With Bradyarrhythmias
Acronym
His Bundle Pacing for Bradyarrhythmias
Scientific Title
Evaluation of Electrophysiological Parameters related to His Bundle Pacing in Patients With Bradyarrhythmias
Scientific Title:Acronym
His Bundle Pacing for Bradyarrhythmias
Region
| Japan |
Condition
Condition
Bradyarrhythmias
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify characteristics of electrophysiological parameters of optimal site for His bundle pacing
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intracardiac potential and electrohysiological parameters recorded by His bundle pacing lead pre and post placement.
Key secondary outcomes
During 12 months after implant
1) Threshold and impedance of His bundle pacing
2) Amplitude of intracardiac potential
3) Complications related to His bundle 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) pacemaker indication class I or class IIa;
2) intrinsic and minimum QRS duration of less than 150ms; 3) HBP lead implant guided by EP recording system
Key exclusion criteria
1) age of equal and more than 90 years-old and of less than 20 years-old;
2) left ventricular ejection fraction of less than 50%.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University, School of Medicine
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
+81-422-47-5511
toshiaki_sato@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University, School of Medicine
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
+81-422-47-5511
Homepage URL
toshiaki_sato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
School of Medicine
Division of Advanced Arrhythmia Management
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
School of Medicine
Division of Advanced Arrhythmia Management
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
+81-422-47-5511
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
| 2018 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jacep.2020.09.018
Number of participants that the trial has enrolled
50
Results
Overall, local ventricular thresholds were elevated during follow-up. The distal and proximal HBP thresholds did not differ. The local ventricular thresholds of distal HBP were significantly lower than those of proximal HBP. Optimal values of the ventricular measurements at implantation were determined for predicting the accepted ventricular threshold at 6 months. Distal HBP supported by stable local ventricular capture may be useful for treating pacing-dependent patients.
Results date posted
| 2020 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 24 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Fifty patients with bradycardia (58% with atrioventricular block) underwent successful HBP and were followed
for 1 year. Precise locations of the lead tips were confirmed using follow-up echocardiography.
Management information
Registered date
| 2018 | Year | 02 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035808
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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