LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS

Prospective, observational, single-center, non-randomized study of a stand-alone procedure for the exclusion of the LAA with the LARIAT RS in patients with atrial fibrillation. Completed LAA exclusion will be assessed by TEE.

Inclusion criteria

• Age ≥ 21 years
• Diagnosed non-valvular atrial fibrillation
• Current CHADS2 score ≥ 2
• Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban)
• Life expectancy of ≥ 1 year
• Willing and able to provide written informed consent
• Willing and able to come to and comply with scheduled follow-up visits

Exclusion criteria

• Previous cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery)
• Prosthetic heart valve or ring in any position
• Current NYHA Class IV heart failure symptoms
• Current right heart failure
• Myocardial infarction or unstable angina within last 3 months
• Current cardiogenic shock or hemodynamic instability
• Current symptomatic carotid disease
• Need for an intra-aortic balloon pump or intravenous inotropes
• Embolic stroke or transient ischemic attack (TIA) within the last 30 days.
• Current diagnosis of active systemic infection
• Need for emergent cardiac surgery (e.g., cardiogenic shock)
• Current renal failure requiring dialysis
• Current clinical evidence of cirrhosis
• Any history of thoracic radiation
• Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases
• Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders)
• Any history of pericarditis
• Pectus excavatum (clinically defined by treating physician)
• Severe scoliosis
• Pregnancy or desire to get pregnant within the next 12 months.
• LVEF < 30%
• Current participation in a clinical investigation that involves an active treatment arm.
• Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
• Any other criteria, which would make the patient unsuitable to participate in this study as determined by clinical site Principal Investigator (e.g., an uncontrolled drug and/or alcohol addiction)