UMIN-CTR Clinical Trial

Basic information
Public title	The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Acronym	The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Scientific Title	The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Scientific Title:Acronym	The comparison of voltage guide and non-voltage guide PVI in patients with atrial fibrillation.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of voltage guide PVI in atrial fibrillation ablation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The recurrence rate of atrial fibrillation in one year.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	To perform voltage guide PVI
Interventions/Control_2	To perform non-voltage guide PVI
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	To perform 1st session of PVI
Key exclusion criteria	To have previous AF ablation
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Kishihara
Organization	Kitasato university school of medicine
Division name	Department of cardiovascular medicine
Zip code	2520374
Address	Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
TEL	042-778-8111
Email	j_kishihara@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Kishihara
Organization	Kitasato university school of medicine
Division name	Department of cardiovascular medicine
Zip code	2520374
Address	Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
TEL	042-778-8111
Homepage URL
Email	j_kishihara@med.kitasato-u.ac.jp

Sponsor
Institute	Kitasato university
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)

IRB Contact (For public release)
Organization	The institutional ethics committee of hospital of the Kitasato University School of Medicine.
Address	Kitasato1-15-1, Minami-ku, Sagamihara, JAPAN
Tel	042-7778-8111
Email	rinrib@med.kitasato-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	昭和大学横浜市北部病院（神奈川県）、聖マリアンナ医科大学横浜市西部病院（神奈川県）、仙台厚生病院（宮城県）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 02 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048315

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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