UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029013
Receipt number R000032956
Scientific Title An observational study to evaluate usefulness of ultra-high resolution mapping for superior vena cava isolation
Date of disclosure of the study information 2017/09/06
Last modified on 2017/09/05 20:41:37

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Basic information

Public title

An observational study to evaluate usefulness of ultra-high resolution mapping for superior vena cava isolation

Acronym

Ultra-high resolution mapping in SVC isolation

Scientific Title

An observational study to evaluate usefulness of ultra-high resolution mapping for superior vena cava isolation

Scientific Title:Acronym

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

1st name
Middle name
Last name Yasuaki Tanaka

Organization

Yokosuka Kyosai Hospital

Division name

Cardiovascular Center

Zip code


Address

1-16, Yonegahamadori, Yokosuka, Kanagawa

TEL

+81468222710

Email

yasuaki@mxk.mesh.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuaki Tanaka

Organization

Yokosuka Kyosai Hospital

Division name

Cardiovascular Center

Zip code


Address

1-16, Yonegahamadori, Yokosuka, Kanagawa

TEL

+81468222710

Homepage URL


Email

yasuaki@mxk.mesh.ne.jp


Sponsor or person

Institute

Yokosuka Kyosai 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


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Open public recruiting

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032956


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name