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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028186
Receipt No. R000025186
Scientific Title Multicenter retrospective study of surgical ablation for atrial fibrillation during aortic valve replacement
Date of disclosure of the study information 2017/09/01
Last modified on 2019/07/22

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Basic information
Public title Multicenter retrospective study of surgical ablation for atrial fibrillation during aortic valve replacement
Acronym Multicenter retrospective study of surgical ablation for atrial fibrillation during aortic valve replacement
Scientific Title Multicenter retrospective study of surgical ablation for atrial fibrillation during aortic valve replacement
Scientific Title:Acronym Multicenter retrospective study of surgical ablation for atrial fibrillation during aortic valve replacement
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the current status and the benefit of surgical ablation for atrial fibrillation during aortic valve replacement in multicenter retrospective study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes heart rhythm (sinus rhythm or atrial fibrillation) at 3 and 24 months postoperatively and MACCE(major adverse cardiovascular and cerebral event)
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 Cases with atrial fibrillation regardless its etiology from 20 to 80 years old who underwent elective, first time aortic valve replacement.
Key exclusion criteria (1) emergent surgery such as acute aortic dissection or infective endocarditis
(2) concomitant cardiovascular surgery except for CABG, aortic root replacement
(3) hypothermic operation with circulatory arrest
(4) history of implantation of pacemaker
(5) history of catheter-based ablation
(6) off-pump operation such as TAVI
(7) preoperative use of catecholamine
(8) with thrombus in the left atrial(not exclude the cases with thrombus in the left atrial appendage alone)
(9) left atrial diameter >70 mm
(10) who can not be isolated pulmonary veins
(11) who request to withdraw own date
(12) whom the doctors judge inappropriate for this study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Nitta
Organization Nippon Medical School Hospital
Division name Cardiovascular Surgery
Zip code 113-0022
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-0022, Japan
TEL 03-5814-6219
Email nitta@nms.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kunihara
Organization The Jikei University
Division name Cardiac Surgery
Zip code 105-8461
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 106-0031, Japan
TEL 03-3433-1111
Homepage URL
Email kunihara@jikei.ac.jp

Sponsor
Institute Japanese Society For Arrhythmia Surgery
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Jikei University
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo 106-0031, Japan
Tel 03-3433-1111
Email kunihara@jikei.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

Other administrative information
Date of disclosure of the study information
2017 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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To observe the effect of surgical ablation for atrial fibrillation during aortic valve replacement

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025186

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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