Ischemic Stroke, Systemic Embolism
Conditions
Brief summary
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
Interventions
DEVICEAtriClip LAA Exclusion System
LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
Sponsors
AtriCure, Inc.
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | Common termination point (median follow-up for 5 years) | Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure. |
| Primary Safety Endpoint | 30 days post index procedure | Occurrence of at least one of the following events assessed through 30 days post index procedure: * Pericardial effusion requiring percutaneous or surgical treatment * Major bleeding attributable to index surgical procedure * Deep sternal wound infection * Myocardial infarction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Powered Secondary Effectiveness endpoint | Common termination point (median follow-up for 5 years) | Time to the first occurrence of ischemic stroke or systemic arterial embolism |
Countries
Australia, Austria, Belgium, Canada, Czechia, Germany, New Zealand, Spain, United Kingdom, United States
Contacts
STUDY_CHAIRRichard Whitlock, MD
McMaster University
Outcome results
None listed