UMIN-CTR Clinical Trial

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