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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016129
Receipt No. R000018712
Scientific Title Multicenter prospective randomized study of surgical ablation for atrial fibrillation during non-mitral cardiac operation
Date of disclosure of the study information 2015/01/06
Last modified on 2015/01/06

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Basic information
Public title Multicenter prospective randomized study of surgical ablation for atrial fibrillation during non-mitral cardiac operation
Acronym SANMORITZ study: Surgical Ablation for Non Mitral Operation: Randomized multi-Institutional Trial and optimiZation
Scientific Title Multicenter prospective randomized study of surgical ablation for atrial fibrillation during non-mitral cardiac operation
Scientific Title:Acronym SANMORITZ study: Surgical Ablation for Non Mitral Operation: Randomized multi-Institutional Trial and optimiZation
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the benefit of surgical ablation for atrial fibrillation during non-mitral cardiac operation in multicenter prospective randomized 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) and MACCE(major adverse cardiovascular and cerebral event)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1. Resection of left atrial appendage with or without PVI (pulmonary vein isolation) for paroxysmal atrial fibrillation
Interventions/Control_2 2. PVI or full Maze operation in addition to resection of left atrial appendage for persistent or long-standing persistent atrial fibrillation
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 from 20 to 80 years old who undergo elective, first time on-pump coronary artery bypass grafting or aortic valve replacement and give their documentary consent to this study
Key exclusion criteria (1) emergent surgery such as acute aortic dissection or infective endocarditis
(2) hypothermic operation with circulatory arrest
(3) history of implantation of pacemaker
(4) History of catheter-based ablation
(5) off-pump operation such as OPCAB or TAVI
(6) preoperative use of catecholamine
(7) who can not give their documentary consent
(8) with thrombus in the left atrial
(9) left atrial diameter >70 mm
(10) who can not be isolated pulmonary veins
(11) whom the doctors judge inappropriate for this study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kunihara
Organization The Cardiovascular Institute
Division name Cardiovascular Surgery
Zip code
Address 106-0031 3-2-19 Nishiazabu Minato-ku Tokyo
TEL 03-3408-2151
Email kunihara@cvi.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kunihara
Organization The Cardiovascular Institute
Division name Cardiovascular Surgery
Zip code
Address 106-0031 3-2-19 Nishiazabu Minato-ku Tokyo
TEL 03-3408-2151
Homepage URL
Email kunihara@cvi.or.jp

Sponsor
Institute The Cardiovascular Institute Academic Research Organization
Institute
Department

Funding Source
Organization Century Medical, Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 01 Month 06 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
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 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
2015 Year 01 Month 06 Day
Last modified on
2015 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018712

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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