UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040750 |
|---|---|
| Receipt number | R000046525 |
| Scientific Title | The Characteristics and Efficacy of Radiofrequency Catheter Ablation of Focal Atrial Tachycardia Arising from an Epicardial Site |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/06/13 11:16:58 |
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Basic information
Public title
The Characteristics and Efficacy of Radiofrequency Catheter Ablation of Focal Atrial Tachycardia Arising from an Epicardial Site
Acronym
Epi-AT study
Scientific Title
The Characteristics and Efficacy of Radiofrequency Catheter Ablation of Focal Atrial Tachycardia Arising from an Epicardial Site
Scientific Title:Acronym
Epi-AT study
Region
| Japan |
Condition
Condition
atrial tachycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to elucidate the prevalence, characteristics, and outcome after radiofre-quency catheter ablation of epicardial origin atrial tachycardia and to reveal the association between the atrial tachycardia and the epicardial structures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the acute success rate, complication rate, and recurrence rate of catheter ablation procedures of epicardial origin atrial tachycardia and to compare to the anatomical data obtained from cardiac computed tomography.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
From April 2016 to April 2018, 42 consecutive patients with a total of 49 non-reentrant focal ATs were referred to the Nippon Medical School Main Hospital and underwent a radiofre-quency CA.
Key exclusion criteria
none
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Teppei |
| Middle name | |
| Last name | Yamamoto |
Organization
Nippon Medical School
Division name
Department of Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81338222132
s7096@nms.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Yamamoto |
Organization
Nippon Medical School
Division name
Department of Cardiovascular Medicine
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
+81338222131
Homepage URL
s7096@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
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
The ethics committee of Nippon Medical School main hospital
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
+81338222132
inq-ccr@nms.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
| 2020 | Year | 06 | Month | 15 | 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
42
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
| 2018 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyzed the clinical characteristics of the patients, electrocardiographic and electro-physiology properties of the ATs, and results of the CA. For each patient, the data were ob-tained from the patient chart, body surface electrocardiograms before, during and after the electrophysiology study, 24-hour Holter monitoring, echocardiography, and intracardiac electrograms during the electrophysiology study.
Management information
Registered date
| 2020 | Year | 06 | Month | 13 | Day |
Last modified on
| 2020 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046525
| Research Plan | |
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| 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 |
