Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Purpose
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.
Conditions
- Ischemic Stroke
- Systemic Embolism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- AtriCure, Inc.