UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052414 |
|---|---|
| Receipt number | R000059830 |
| Scientific Title | The Success Rate of Ventricular Arrhythmia Conversion in Subcutaneous ICD patients with Low-Energy Shock Delivery at Defibrillation Threshold Testing |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2025/04/20 06:01:30 |
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Basic information
Public title
The Success Rate of Ventricular Arrhythmia Conversion in Subcutaneous ICD patients with Low-Energy Shock Delivery at Defibrillation Threshold Testing
Acronym
The Success Rate of Ventricular Arrhythmia Conversion in Subcutaneous ICD patients with Low-Energy Shock Delivery at Defibrillation Threshold Testing
Scientific Title
The Success Rate of Ventricular Arrhythmia Conversion in Subcutaneous ICD patients with Low-Energy Shock Delivery at Defibrillation Threshold Testing
Scientific Title:Acronym
The Success Rate of Ventricular Arrhythmia Conversion in Subcutaneous ICD patients with Low-Energy Shock Delivery at Defibrillation Threshold Testing
Region
| Japan |
Condition
Condition
lethal arrhythmia
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Defibrillation Threshold Testing at Low Power for Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Implantation: Success Rates Reveal Efficacy and Safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the success rate of defibrillation threshold testing for subcutaneous implantable cardioverter-defibrillators (S-ICDs) at low power at the time of implantation.
Key secondary outcomes
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
Patients with SICD indications
Key exclusion criteria
Patients deemed ineligible by the physician in charge.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Asano |
Organization
Showa University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8000
t-asano@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Asano |
Organization
Showa University School of Medicine
Division name
Division of Cardiology, Department of Medicine
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8000
Homepage URL
t-asano@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
none
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-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
| 2023 | Year | 11 | Month | 01 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Success Rate of SICD Defibrillation Test in Japanese
The study period was extended to 2024/5/10 due to slow growth in case enrollment.
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059830
