Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000050651
Ethics application status
Approved
Date submitted
8/01/2014
Date registered
17/01/2014
Date last updated
14/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the AtriClip for completeness of left atrial appendage closure in cardiac surgery patients with concomitant atrial fibrillation
Scientific title
Evaluation of the AtriClip for completeness of left atrial appendage closure in cardiac surgery patients with concomitant atrial fibrillation
Secondary ID [1] 283555 0
none
Universal Trial Number (UTN)
U1111-1150-0735
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation in cardiac surgery patients 290461 0
Condition category
Condition code
Cardiovascular 290853 290853 0 0
Other cardiovascular diseases
Surgery 291271 291271 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Left atrial appendage closure with AtriClip LAA exclusion system. The AtriClip is a polyester fabric covered titanium clip. It is placed with the use of an applicator and adds about 5 to 10 minutes to the cardiac surgical procedure time
Intervention code [1] 288247 0
Treatment: Devices
Intervention code [2] 288601 0
Treatment: Surgery
Comparator / control treatment
No control group. Results are compared with reports from the literature.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290849 0
Completeness left atrial appendage closure. Post operative trans esophageal echocardiogram is used to assess left atrial appendage closure
Timepoint [1] 290849 0
3-6 months post operatively
Secondary outcome [1] 305438 0
Bleeding from left atrial appendage. Assessed intra-operatively and by observing post-operative blood loss.
Timepoint [1] 305438 0
first week post-operatively
Secondary outcome [2] 306402 0
Neurological events (stroke, TIA). Assessed via medical history and radiological investigation as indicated.
Timepoint [2] 306402 0
3-6 months
Secondary outcome [3] 306403 0
Thromboembolic events.
Timepoint [3] 306403 0
3-6 month post operatively. Assessed via medical history and radiological investigation or ultrasonography as indicated.
Secondary outcome [4] 306404 0
Easy of application
Timepoint [4] 306404 0
Intraoperatively the surgeon rates ease of application 1-5 (easy - difficult) and aortic cross clamp time and cardiopulmonary bypass time are noted
Secondary outcome [5] 306405 0
Postoperative length of stay
Timepoint [5] 306405 0
Post-operative hospital stay is monitored
Secondary outcome [6] 306406 0
presence of atrial fibrillation.
Timepoint [6] 306406 0
3-6 months post operatively with ECG +/- holter monitoring

Eligibility
Key inclusion criteria
Cardiac surgery patients with concomitant atrial fibrillation
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Redo surgery patients, Left atrial appendage thrombus, nickle-titanium alloy or nitinol allergy

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At the pre-operative assessment process, patient in atrial fibrillation undergoing concomitant cardiac surgery via a sternotomy, will be recruited. Enrolled patients will recieve treatment. There is no comparision group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The percentage of patients who have complete exclusion of the left atrial appendage after the Atriclip will be obtained using intra-operative and post-operative transoesophageal echocardiogram.
All continuous variables will be summarized using descriptive statistics, including the mean, standard deviation, median, quartiles, minimum and maximum. All categorical variables will be summarized using the number and percent of subjects within each category. The variables that will be described are: Age, Sex, ease of application, aortic cross clamp time, Cardiopulmonary bypass time, complications (CVA, TIA, Bleeding from atrial appendage, thromboembolism), length of stay, presence of atrial fibrillation.
A one proportion test will be used to assess our closure rate compared to previous studies.

We hypothesised a percentage of 90% of complete exclusion of the left atrial appendage using the AtriClip , and previous studies showed rates of approximately 60% with the various other techniques. With 20 patients we could detect a significant difference of 27% with 80% power and a 5% level of significance, which is sufficient to determine effectiveness of the AtriClip.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1674 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 7550 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 288239 0
Commercial sector/Industry
Name [1] 288239 0
N Stenning & Co Ltd
Country [1] 288239 0
Australia
Primary sponsor type
Individual
Name
Dr L Sanders
Address
Sir Charles Gairdner hospital, Hospital Ave, Nedlands, WA6009
Country
Australia
Secondary sponsor category [1] 286957 0
Individual
Name [1] 286957 0
J Passage
Address [1] 286957 0
Sir Charles Gairdner Hospital, Hospital ave, Nedlands, WA6009
Country [1] 286957 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290144 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 290144 0
Sir Charles Gairdner hosp, Hospital avenue, Nedlands, WA6009
Ethics committee country [1] 290144 0
Australia
Date submitted for ethics approval [1] 290144 0
Approval date [1] 290144 0
15/10/2013
Ethics approval number [1] 290144 0
Quality improvement No 4333

Summary
Brief summary
The left atrial appendage (LAA) is the most common source of thrombus in patients with atrial fibrillation (AF). Such thrombus has the potential to embolise to the brain, causing stroke.
Ligation of the appendage is a commonly performed concomitant procedure in patients with AF undergoing heart surgery for other reasons . Current literature suggests that complete exclusion of the left atrial appendage occurs in only 40% of patients undergoing ligation and intra-atrial closure. A small amount of data suggests better long term exclusion of the LAA with the Atriclip device. In addition there is little risk of bleeding compare to excision and oversewing. We would like to collect data on patients undergoing left atrial appendage ligation using the Atriclip device
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36746 0
Dr Lucas H Sanders
Address 36746 0
Sir Charles Gairdner hospital, hospital avenue, Nedlands, WA6009
Country 36746 0
Australia
Phone 36746 0
+61893463333
Fax 36746 0
Email 36746 0
[email protected]
Contact person for public queries
Name 36747 0
Dr Lucas H Sanders
Address 36747 0
Sir Charles Gairdner hospital, hospital avenue, Nedlands, WA6009
Country 36747 0
Australia
Phone 36747 0
+61893463333
Fax 36747 0
Email 36747 0
[email protected]
Contact person for scientific queries
Name 36748 0
Dr Lucas H Sanders
Address 36748 0
Sir Charles Gairdner hospital, hospital avenue, Nedlands, WA6009
Country 36748 0
Australia
Phone 36748 0
+61893463333
Fax 36748 0
Email 36748 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.