UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028186 |
|---|---|
| Receipt number | 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 17:21:18 |
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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
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
kunihara@jikei.ac.jp
Sponsor or person
Institute
Japanese Society For Arrhythmia Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025186
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
