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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040196
Receipt No. R000045834
Scientific Title Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Date of disclosure of the study information 2020/07/01
Last modified on 2020/04/19

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Basic information
Public title Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Acronym Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Scientific Title Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Scientific Title:Acronym Utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation in a multicenter randomized study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate an utility of the earliest pulmonary vein potential-guided cryoballoon ablation for atrial fibrillation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence at 12 months after the ablation
Key secondary outcomes Time to isolation of pulmonary vein potential, procedure time, cryoballoon ablation time, early recurrence...etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Pulmonary vein potential-guided cryoballoon ablation
Interventions/Control_2 Control group (conventional cryoballoon ablation)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with paroxysmal atrial fibrillation who are scheduled for cryoballoon ablation
Key exclusion criteria -Persistent atrial fibrillation
-Impaired renal function/hemodialysis
-Common pulmonary vein anatomy
Target sample size 124

Research contact person
Name of lead principal investigator
1st name Toyoaki
Middle name
Last name Murohara
Organization Nagoya University Graduate School of Medicine
Division name Department of Cardiology
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL 81-52-744-2147
Email murohara@med.nagoya-u.ac.jp.

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Yanagisawa
Organization Nagoya University Graduate School of Medicine
Division name Department of Advanced Cardiovascular Therapeutics
Zip code 466-8550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL 81-52-744-2147
Homepage URL
Email yanagisawa-sato@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
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 Nagoya University Graduate School of Medicine Institutional Review Board
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
Tel 81-52-744-2942
Email camcr@med.nagoya-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 市立四日市病院(三重県)、安城更生病院(愛知県)、名古屋市立大学病院(愛知県)、トヨタ記念病院(愛知県)、小牧市民病院(愛知県)

Other administrative information
Date of disclosure of the study information
2020 Year 07 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 04 Month 18 Day
Date of IRB
Anticipated trial start date
2023 Year 03 Month 31 Day
Last follow-up date
2024 Year 03 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 04 Month 19 Day
Last modified on
2020 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045834

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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