UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054126 |
|---|---|
| Receipt number | R000061808 |
| Scientific Title | Retrospective observational study about the efficacy and safety of intrinsic antitachycardia pacing |
| Date of disclosure of the study information | 2024/04/11 |
| Last modified on | 2025/04/12 11:34:25 |
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Basic information
Public title
Retrospective observational study about the efficacy and safety of intrinsic antitachycardia pacing
Acronym
safe iATP
Scientific Title
Retrospective observational study about the efficacy and safety of intrinsic antitachycardia pacing
Scientific Title:Acronym
safe iATP
Region
| Japan |
Condition
Condition
ventricular tachycardia(VT)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the efficacy and safety of the iATP for VT compared to the cATP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary study endpoint was the ATP success rate for ventricular arrhythmia.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In patients underwent de novo ICD or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implantation in our hospital, we analyzed the patients who had appropriate ATP therapy for ventricular arrhythmia between August 2020 and August 2023.
Key exclusion criteria
Patients who were (1) implanted with CobaltTM devices but had the settings intentionally changed from the iATP to the cATP by the operator, (2) lacking detailed records of ATP episodes, or (3) performed manual ATP during ablation procedures or in the emergency department or other similar situations, were excluded.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Koumei |
| Middle name | |
| Last name | Onuki |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
8020001
Address
3-2-1 Asano, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
TEL
0935112000
umixsirakawa@gmail.com
Public contact
Name of contact person
| 1st name | Koumei |
| Middle name | |
| Last name | Onuki |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
8020001
Address
3-2-1 Asano, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
TEL
0935112000
Homepage URL
umixsirakawa@gmail.com
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kokura Memorial Hospital
Address
3-2-1 Asano, Kokurakita Ward, Kitakyushu City, Fukuoka Prefecture
Tel
0935112000
umixsirakawa@gmail.com
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 | 04 | Month | 11 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC11730729/
Publication of results
Unpublished
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC11730729/
Number of participants that the trial has enrolled
128
Results
There was no significant difference in ATP success rate (91.8% vs. 92.7%, p = .645) or in acceleration rate (1.1% vs. 2.4%, p = .274). However, when limited to episodes in which VT was not terminated by a single ATP and propensity score matching was performed, the iATP showed a higher VT termination rate (84.1% vs. 53.6%, p < .001) and a lower acceleration rate (0% vs. 10.1%, p = .013) than the cATP.
Results date posted
| 2025 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
128 patients and 1962 ventricular tachycardia (VT) episodes treated with the iATP or the cATP at Kokura Memorial Hospital.
Participant flow
Patients were categorized into two groups: the iATP group (23 patients, 182 episodes) and the cATP group (105 patients, 1780 episodes).
Adverse events
none
Outcome measures
The primary outcome was the ATP success rate for VT. Success per episode was defined as VT termination without the need for shock therapy, while success per patient was defined as all episodes with successful termination by ATP therapy. The secondary outcomes were all-cause mortality per patient and acceleration rate per episode.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical follow-up data were systematically gathered from medical records or via telephone contact with the patients, their families, or referring physicians. In patients with a history of multiple ATP therapies, clinical data at a certain point (including medication, ECG findings, and whether VT ablation was performed) were recorded using the data from the last appropriate ATP activation. The underlying diseases were classified into Ischemic Cardiomyopathy (ICM), Dilated Cardiomyopathy (DCM), Cardiac Sarcoidosis, Cardiac Amyloidosis, and Others. VT storm was defined as more than 10 episodes per day. The follow-up period for patients who had the device implanted before August 1, 2020, started on August 1, 2020, and for those implanted after this date, it began on the day of surgery. The end of the follow-up period was defined as the day the follow-up was discontinued, the day of death, or August 31, 2023, if neither of the former conditions applied.
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061808
