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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023746
Receipt No. R000027352
Scientific Title The study of the efficacy of new generation cryoablation system (CryoICE) in the surgical treatment of atrial fibrillation
Date of disclosure of the study information 2016/09/01
Last modified on 2018/03/01

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Basic information
Public title The study of the efficacy of new generation cryoablation system (CryoICE) in the surgical treatment of atrial fibrillation
Acronym The study of the efficacy or cryoablation system (CryoICE)
Scientific Title The study of the efficacy of new generation cryoablation system (CryoICE) in the surgical treatment of atrial fibrillation
Scientific Title:Acronym The study of the efficacy or cryoablation system (CryoICE)
Region
Japan

Condition
Condition Atrial fibrillation
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of cryoablation system (CryoICE) in the surgical treatment of atrial fibrillation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The success rate of restoring sinus rhythm
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Cryoablation of the atrium
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have indication of surgery of atrial fibrillation in accordance with the guidelines (JCS 2011)
Key exclusion criteria Patients who deny participating in this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shun-ichiro Sakamoto
Organization Nippon Medical School
Division name Department of Cariovascular Surgery
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-5814-6219
Email saka-165@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Kawase
Organization Nippon Medical School
Division name Department of Cariovascular Surgery
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-5814-6219
Homepage URL
Email yasu@nms.ac.jp

Sponsor
Institute Nippon Medical School, Department of Cariovascular Surgery
Institute
Department

Funding Source
Organization Nippon Medical School, Department of Cariovascular Surgery
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 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 Terminated
Date of protocol fixation
2016 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 24 Day
Last modified on
2018 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027352

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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