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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036505
Receipt No. R000040753
Scientific Title Atrial pacing to unmask the presence of epicardial muscular fibers connecting the right-sided pulmonary veins and right atrium
Date of disclosure of the study information 2019/04/15
Last modified on 2019/04/14

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Basic information
Public title Atrial pacing to unmask the presence of epicardial muscular fibers connecting the right-sided pulmonary veins and right atrium
Acronym Epicardial muscular fibers connecting the right-sided PVs and RA
Scientific Title Atrial pacing to unmask the presence of epicardial muscular fibers connecting the right-sided pulmonary veins and right atrium
Scientific Title:Acronym Epicardial muscular fibers connecting the right-sided PVs and RA
Region
Japan

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

Objectives
Narrative objectives1 To electrophysiologically prove the presence of epicardial muscular connections between the right atrium and pulmonary venous carina
Basic objectives2 Others
Basic objectives -Others To evaluate the efficacy of catheter ablation of the epicardial connections
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Accuracy of the differential pacing methods.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Pacing manuevers at the pulmonary veins and atrium during catheter ablation of atrial fibrillation
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 and presented to the laboratory in sinus rhythm
Key exclusion criteria long-standing persistent atrial fibrillation
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Yoshida
Organization Ibaraki Prefectural Central Hospital
Division name Depertment of Cardiology
Zip code 309-1793
Address 6528 Koibuchi, Kasama, Ibaraki
TEL 0296-77-1121
Email kentaroyo@nifty.com

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Yoshida
Organization Ibaraki Preferal Central Hospital
Division name Depertment of Cardiology
Zip code 309-1793
Address 6528 Koibuchi, Kasama, Ibaraki
TEL 0296-77-1121
Homepage URL
Email kentaroyo@nifty.com

Sponsor
Institute Ibaraki Prefectural Central Hospital
Institute
Department

Funding Source
Organization University of Tsukuba
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 Ibaraki Prefectural Central Hospital
Address 6528 Koibuchi, Kasama, Ibaraki
Tel 0296-77-1121
Email j-kishi@chubyoin.pref.ibaraki.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
2019 Year 04 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
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
2019 Year 02 Month 07 Day
Date of IRB
2019 Year 03 Month 07 Day
Anticipated trial start date
2019 Year 03 Month 08 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 14 Day
Last modified on
2019 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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