UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016129 |
|---|---|
| Receipt number | 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 11:57:26 |
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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
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
kunihara@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute Academic Research Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018712
