UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of the efficacy of new generation cryoablation system (CryoICE) in the surgical treatment of atrial fibrillation
Title of the study (Brief title)	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	Shun-ichiro Sakamoto
Organization	Nippon Medical School
Division name	Department of Cariovascular Surgery
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-5814-6219
Email	saka-165@nms.ac.jp

Public contact
Name of contact person	Yasuhiro Kawase
Organization	Nippon Medical School
Division name	Department of Cariovascular Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 08 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027352