Atrial Fibrillation
Conditions
Keywords
Left Atrial Appendage, LARIAT, atrial fibrillation, contraindication to oral anticoagulation therapy
Brief summary
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic events who are contraindicated for or intolerant of oral anticoagulation therapy. This study will enroll 100 participant, who will receive the LAA ligation study treatment. The objective of this registry is to assess the effectiveness of permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard anticoagulation therapy. The results of the study will be used to assess outcomes within the first year, post-treatment.
Interventions
DEVICELARIAT Suture Delivery Device and Accessories
Sponsors
AtriCure, Inc.
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 21 years 2. Diagnosed non-valvular atrial fibrillation 3. Current CHADS2 score \> 2 4. Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e., warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following: history of bleeding or high risk of bleeding; labile INR level (While on anticoagulation therapy, participant had INR results out of therapeutic range \> 40% of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy). 5. Life expectancy of at least 1 year 6. Willing and able to return and comply with scheduled follow up visits 7. Willing and able to provide written informed consent
Exclusion criteria
1. Prior cardiac surgery involving opening of pericardium (e.g., CABG, heart transplantation, valve surgery) 2. Prosthetic heart valve or ring in any position 3. Current NYHA Class IV heart failure symptoms 4. Current right heart failure 5. Myocardial infarction within last 3 months 6. Unstable angina within last 3 months 7. Current cardiogenic shock or hemodynamic instability 8. Current symptomatic carotid disease 9. Need for an intra-aortic balloon pump or intravenous inotropes 10. Embolic stroke within the last 30 days 11. Transient ischemic attack (TIA) within the last 30 days 12. Current diagnosis of active systemic infection 13. eGFR \< 60 mL/min/1.73m2 within last 3 months 14. Current renal failure requiring dialysis 15. ALT or AST level \> 3 times upper level of normal, indicating hepatic failure. (NOTE: normal range provided by local laboratory performing the measurement), based on most recent pre-procedure assessment (within 30 days of study treatment) 16. Current clinical evidence of cirrhosis 17. Any history of thoracic radiation 18. Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases 19. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders) 20. Any history of pericarditis 21. Pectus excavatum (clinically defined by treating physician) 22. Severe scoliosis 23. Thrombocytopenia (platelet count \< 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment) 24. Anemia with hemoglobin concentration of \< 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment) 25. Pregnancy or desire to get pregnant within next 12 months. 26. Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry 27. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study 28. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete exclusion | During 1 year follow-up. | To assess the rate of complete exclusion of the left atrial appendage (defined as \< 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of procedural success | Baseline | Exploratory objectives include assessment of the rate of procedural success (defined as completion of the procedure as intended at baseline, as assessed by the clinical site Principal Investigator) |
| Rate of complications | During 1 year follow-up | Exploratory objectives include assessment of the rate of complications related to the use of the LARIAT and accessories |
Countries
Germany, Poland, United States
Outcome results
None listed