UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019388 |
|---|---|
| Receipt number | R000022421 |
| Scientific Title | Left Atrial Appendage Occlusion Study III |
| Date of disclosure of the study information | 2015/10/16 |
| Last modified on | 2015/10/21 13:19:03 |
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Basic information
Public title
Left Atrial Appendage Occlusion Study III
Acronym
Left Atrial Appendage Occlusion Study (LAAOS) III
Scientific Title
Left Atrial Appendage Occlusion Study III
Scientific Title:Acronym
Left Atrial Appendage Occlusion Study (LAAOS) III
Region
| Japan | North America | South America |
| Australia | Europe |
Condition
Condition
Patients with atrial fibrillation/flutter undergoing on-pump cardiac surgery
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether removing the left atrial appendage can reduce stroke and other complications
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The first occurrence of ischemic stroke or transient ischemic attack with positive neuroimaging or systemic arterial embolism over the duration of follow-up.
Key secondary outcomes
1) total mortality
2) post-operative safety outcomes (chest tube output in the first 24 hours post-surgery, post-operative re-exploration for bleeding in the first 48 hours postsurgery, and 30-day mortality)
3) the incidence of re-hospitalization for heart failure
4) the incidence of major bleeding
5) the incidence of myocardial infarction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Left atrial appendage occlusion
Interventions/Control_2
Non-left atrial appendage occlusion
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age >= 18 years of age
2) Undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass
3) A documented history of atrial fibrillation or atrial flutter
4) CHA2DS2-VASc score >=2
5) Written informed consent
Key exclusion criteria
1) Patients undergoing any of the following procedures:
a. Off-pump cardiac surgery
b. Heart transplant
c. Complex congenital heart surgery
d. Sole indication for surgery is ventricular assist
device insertion
e. Previous cardiac surgery (re-operation)
f. Mechanical valve implantation
2) Patients who have had a previous placement of a
percutaneous LAA closure device
Target sample size
4700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Richard Whitlock, |
Organization
McMaster University
Division name
Population Health Research Institute
Zip code
Address
237 Barton Street East, C1-114 Hamilton, ON L8L 2X2
TEL
905-527-4322
richard.whitlock@phri.ca
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kate Brady |
Organization
McMaster University
Division name
Population Health Research Institute
Zip code
Address
237 Barton Street East, C1-114 Hamilton, ON L8L 2X2
TEL
905-527-4322
Homepage URL
kate.brady@phri.ca
Sponsor or person
Institute
Population Health Research Institute
Institute
Department
Personal name
Funding Source
Organization
Population Health Research Institute
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Canada
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01561651
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院 （大阪府） Osaka University Hospital, Osaka
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 16 | 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
| 2013 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 19 | 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 | 10 | Month | 16 | Day |
Last modified on
| 2015 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022421
