UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053386 |
|---|---|
| Receipt number | R000060887 |
| Scientific Title | Predictor of A4 amplitude and atrio-ventricular synchrony in patients with leadless pacemaker |
| Date of disclosure of the study information | 2024/01/19 |
| Last modified on | 2024/01/18 14:09:02 |
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Basic information
Public title
Predictor of A4 amplitude and atrio-ventricular synchrony in patients with leadless pacemaker
Acronym
Clinical research related to leadless pacemaker
Scientific Title
Predictor of A4 amplitude and atrio-ventricular synchrony in patients with leadless pacemaker
Scientific Title:Acronym
Predictors associated with leadless pacemakers
Region
| Japan |
Condition
Condition
Bradyarrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the predictors of A4-amplitude and atrio-ventricular synchrony in patients with leadless pacemakers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictors related to A4-amplitude and synchronization rate
Key secondary outcomes
Changes in test indices before and after leadless pacemakers (laboratory tests, echocardiogram), clinical outcome caused by differences in atrial sensing and ventricular pacing rates (atrioventricular synchronization rate); incidence of cardiovascular events, incidence of inpatient non-cardiovascular events, mortality rate, safety (incidence of adverse events by 12 months after treatment)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients from whom written consent was obtained
2) Patients with atrioventricular block or sick sinus syndrome who are eligible for leadless pacemakers.
3) Males and females who are at least 18 years old at the time of consent
Key exclusion criteria
1) Patients who have been deemed unfit by the Research Supervisor
2) Patients given less than one year to live due to any disease
3) Patients for whom preoperative examination could not be obtained, or for whom evaluation is not possible.
4) Males and females who are under 18 years old at the time of consent
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Kato |
Organization
Tottori University Hospital
Division name
Department of Cardiovascular Internal Medicine
Zip code
683-8504
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6517
kato3@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kawatani |
Organization
Tottori University Hospital
Division name
Department of Cardiovascular Internal Medicine
Zip code
683-8504
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6517
Homepage URL
s20rp.fe.lv@gmail.com
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Hospital
Address
36-1 Nishi-cho, Yonago, Tottori
Tel
0859-38-6517
kato3@tottori-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
| 2024 | Year | 01 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 01 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060887
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
