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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032631
Receipt No. R000037206
Scientific Title Value of High-resolution Mapping in Optimizing Cryoballoon Ablation of Atrial Fibrillation
Date of disclosure of the study information 2018/05/17
Last modified on 2018/05/17

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Basic information
Public title Value of High-resolution Mapping in Optimizing Cryoballoon Ablation of Atrial Fibrillation
Acronym Value of High-resolution Mapping in Optimizing Cryoballoon Ablation of Atrial Fibrillation
Scientific Title Value of High-resolution Mapping in Optimizing Cryoballoon Ablation of Atrial Fibrillation
Scientific Title:Acronym Value of High-resolution Mapping in Optimizing Cryoballoon Ablation of Atrial Fibrillation
Region
Japan Europe

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

Objectives
Narrative objectives1 To assess the value of using a high-resolution mapping system during CB ablation procedures in terms of ability in acutely detecting incomplete CB lesions
To compare the Achieve and Orion catheters with respect to pulmonary vein (PV) signals detection at baseline and after CB ablation
To characterize the extension of the lesion produced by CB ablation by means of a high-resolution voltage mapping.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Rate of patients with real-time PVs recordings, revealed by Achieve and Orion catheters, before and after CB ablation.
Key secondary outcomes

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
80 years-old >=
Gender Male and Female
Key inclusion criteria Consecutive patients with drug-resistant paroxysmal or early-persistent AF who underwent PVI by means of CB ablation as the index procedure, assisted by a high-resolution mapping system, were included in this study.
Key exclusion criteria Exclusion criteria was defined as the patients 1) difficult to medical check after procedure, 2) unable to use contrast agents, 3) disagree with enrollment of this study
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Giulio Conte
Organization Cardiocentro Ticino
Division name Division of Cardiology
Zip code
Address Lugano, Switzerland
TEL +41918053350
Email giulio.conte@cardiocentro.org

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Miwa
Organization Kyorin University Hospital
Division name Department of Cardiology
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo
TEL 0422475511
Homepage URL
Email y-miwa@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Cardiology, Kyorin University Hospital
Institute
Department

Funding Source
Organization Kyorin University 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
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 杏林大学医学部付属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 17 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 Completed
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2017 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To assess value of high-resolution mapping system with CB to paroxysmal AF patients

Management information
Registered date
2018 Year 05 Month 17 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037206

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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