UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An observational study to evaluate usefulness of ultra-high resolution mapping for superior vena cava isolation
Title of the study (Brief title)	Ultra-high resolution mapping in SVC isolation
Region	Japan

Condition
Condition	Atrial fibrillation
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate usefulness of of ultra-high resolution mapping for superior vena cava isolation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	technical success of SVC isolation
Key secondary outcomes	electrophysiological findings of SVC assessed by ultra-high resolution mapping complications during SVC isolation

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	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who undergo catheter ablation of atrial fibrillation
Key exclusion criteria	patients with significant cardiac structure disease
Target sample size	100

Research contact person
Name of lead principal investigator	Yasuaki Tanaka
Organization	Yokosuka Kyosai Hospital
Division name	Cardiovascular Center
Address	1-16, Yonegahamadori, Yokosuka, Kanagawa
TEL	+81468222710
Email	yasuaki@mxk.mesh.ne.jp

Public contact
Name of contact person	Yasuaki Tanaka
Organization	Yokosuka Kyosai Hospital
Division name	Cardiovascular Center
Address	1-16, Yonegahamadori, Yokosuka, Kanagawa
TEL	+81468222710
Homepage URL
Email	yasuaki@mxk.mesh.ne.jp

Sponsor
Institute	Yokosuka Kyosai Hospital
Institute
Department

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)

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	2017 Year 09 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Patients with atrial fibrillation who undergo high-resolution superior vena cava mapping during sinus rhythm after pulmonary vein isolation are enrolled. After the mapping, if initiation of atrial fibrillation from SVC is identified, SVC isolation is performed. We evaluate the outcome, the electrophysiological findings, and complications during SVC isolation.

Management information
Registered date	2017 Year 09 Month 05 Day
Last modified on	2017 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032956