UMIN-CTR Clinical Trial

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
Email	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
Email	s7096@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046525