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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05478304




Registration number
NCT05478304
Ethics application status
Date submitted
15/07/2022
Date registered
28/07/2022
Date last updated
4/06/2025

Titles & IDs
Public title
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Scientific title
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Secondary ID [1] 0 0
CP-2021-05
Universal Trial Number (UTN)
Trial acronym
LeAAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke 0 0
Systemic Embolism 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AtriClip LAA Exclusion System

Experimental: Treatment - LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery

No intervention: Control - No LAAE concomitant to and at the time of planned cardiac surgery


Treatment: Devices: AtriClip LAA Exclusion System
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Effectiveness Endpoint
Timepoint [1] 0 0
Common termination point (median follow-up for 5 years)
Primary outcome [2] 0 0
Primary Safety Endpoint
Timepoint [2] 0 0
30 days post index procedure
Secondary outcome [1] 0 0
Powered Secondary Effectiveness endpoint
Timepoint [1] 0 0
Common termination point (median follow-up for 5 years)

Eligibility
Key inclusion criteria
* Subjects = 18 years of age
* Documentation of any of the following clinical criteria:

* CHA2DS2-VASc = 4 with age = 65
* CHA2DS2-VASc = 4 with significant left atrium enlargement or elevated NT-proBNP
* CHA2DS2-VASc = 3 with age = 75
* CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
* CHA2DS2-VASc score = 2 with age = 65 and significant left atrium enlargement or elevated NT-proBNP
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Clinically significant atrial fibrillation or atrial flutter:

* Anytime in the past and
* Documented by an electrocardiographic recording and
* Episode lasting 6 minutes or longer1*
* Prior procedure involving opening the pericardium or entering the pericardial space
* Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
* Planned cardiac surgical procedure using non-sternotomy approaches

o Partial sternotomies will be allowed.
* Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
* Active endocarditis
* Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
* Known allergy to Nitinol or nickel sensitivity
* Known medical condition with expected survival of less than 1 year
* Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
* Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
* Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
* Pregnancy
* Known severe symptomatic carotid disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2032
Actual
Sample size
Target
6500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Victorian Heart Hospital and Monash University - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maryland
Country [19] 0 0
United States of America
State/province [19] 0 0
Massachusetts
Country [20] 0 0
United States of America
State/province [20] 0 0
Michigan
Country [21] 0 0
United States of America
State/province [21] 0 0
Minnesota
Country [22] 0 0
United States of America
State/province [22] 0 0
Mississippi
Country [23] 0 0
United States of America
State/province [23] 0 0
Missouri
Country [24] 0 0
United States of America
State/province [24] 0 0
Nebraska
Country [25] 0 0
United States of America
State/province [25] 0 0
New Jersey
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
South Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
West Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
Wisconsin
Country [39] 0 0
Austria
State/province [39] 0 0
Styria
Country [40] 0 0
Austria
State/province [40] 0 0
Vienna
Country [41] 0 0
Belgium
State/province [41] 0 0
Brabant
Country [42] 0 0
Belgium
State/province [42] 0 0
Brussels
Country [43] 0 0
Canada
State/province [43] 0 0
Alberta
Country [44] 0 0
Canada
State/province [44] 0 0
British Columbia
Country [45] 0 0
Canada
State/province [45] 0 0
New Brunswick
Country [46] 0 0
Canada
State/province [46] 0 0
Nova Scotia
Country [47] 0 0
Canada
State/province [47] 0 0
Ontario
Country [48] 0 0
Canada
State/province [48] 0 0
Quebec
Country [49] 0 0
Canada
State/province [49] 0 0
Québec
Country [50] 0 0
Czechia
State/province [50] 0 0
Brno
Country [51] 0 0
Germany
State/province [51] 0 0
Bavaria
Country [52] 0 0
Germany
State/province [52] 0 0
Brandenburg
Country [53] 0 0
Germany
State/province [53] 0 0
Lower Saxony
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Great Britain
Country [57] 0 0
United Kingdom
State/province [57] 0 0
North Yorkshire
Country [58] 0 0
United Kingdom
State/province [58] 0 0
West Midlands
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AtriCure, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Whitlock, MD
Address 0 0
McMaster University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirstin Smentek
Address 0 0
Country 0 0
Phone 0 0
612.430.1398
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05478304