UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045072
Receipt number R000051382
Scientific Title A Comparative Study of Grid Catheters and Pentaray Catheters for Left Atrial Mapping
Date of disclosure of the study information 2021/09/10
Last modified on 2021/08/05 17:42:46

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Basic information

Public title

A Comparative Study of Grid Catheters and Pentaray Catheters for Left Atrial Mapping

Acronym

Grid Pentaray Study

Scientific Title

A Comparative Study of Grid Catheters and Pentaray Catheters for Left Atrial Mapping

Scientific Title:Acronym

Grid Pentaray Study

Region

Japan


Condition

Condition

atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A study of whether the wave height of left atrial muscle potential changes depending on the catheter used

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference of low voltage area in the left atrium

Key secondary outcomes

Number of points acquired
Number of valid points acquired
Procedure time


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

18 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

To perform 1st session of PVI

Key exclusion criteria

To have previous AF ablation

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Jumpei
Middle name
Last name Saito

Organization

Showa University Yokohama Northern Hospital

Division name

Cardiovascular Medicine

Zip code

224-8503

Address

35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture

TEL

0459497000

Email

saijun0960@yahoo.co.jp


Public contact

Name of contact person

1st name Jumpei
Middle name
Last name Saito

Organization

Showa University Yokohama Northern Hospital

Division name

Cardiovascular Medicine

Zip code

224-8503

Address

35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture

TEL

0459497000

Homepage URL


Email

saijun0960@yahoo.co.jp


Sponsor or person

Institute

Showa University Yokohama Northern Hospital

Institute

Department

Personal name



Funding Source

Organization

Showa University Yokohama Northern Hospital

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

Ethics Committee for Research Involving Human Subjects at Showa University

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

Tel

03-3784-8129

Email

m-rinri@ofc.showa-u.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

2021 Year 09 Month 10 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

26

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

Completed

Date of protocol fixation

2020 Year 06 Month 01 Day

Date of IRB

2021 Year 09 Month 01 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2021 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

non


Management information

Registered date

2021 Year 08 Month 05 Day

Last modified on

2021 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name