Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
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.
Inclusion Criteria:
Subjects ≥ 18 years of age
Documentation of any of the following clinical criteria:
Exclusion Criteria:
Clinically significant atrial fibrillation or atrial flutter:
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
Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
Berlin, Brandenburg 13353, Germany