Atrial Appendage
Conditions
Brief summary
The objective is to assess the effectiveness of permanent exclusion of the LAA with the LARIAT RS Suture Delivery Device and accessories in AF patients.
Detailed description
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.
Interventions
DEVICELARIAT RS Suture Delivery Device
LARIAT RS Suture Delivery Device
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 years 2. Diagnosed non-valvular atrial fibrillation 3. Current CHADS2 score ≥ 2 4. Poor candidate (e.g., contraindicated, labile INR, non-compliant, etc.) for anticoagulation (e.g., warfarin, dabigatran, apixaban, and rivaroxaban) 5. Life expectancy of ≥ 1 year 6. Willing and able to provide written informed consent 7. Willing and able to come to and comply with scheduled follow-up visits
Exclusion criteria
1. Previous 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 or unstable angina within last 3 months 6. Current cardiogenic shock or hemodynamic instability 7. Current symptomatic carotid disease 8. Need for an intra-aortic balloon pump or intravenous inotropes 9. Embolic stroke or transient ischemic attack (TIA) within the last 30 days. 10. Current diagnosis of active systemic infection 11. Need for emergent cardiac surgery (e.g., cardiogenic shock) 12. Current renal failure requiring dialysis 13. Current clinical evidence of cirrhosis 14. Any history of thoracic radiation 15. Current use of long term treatment with steroids, not including intermittent use of inhaled steroids for respiratory diseases 16. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific connective tissue disorders) 17. Any history of pericarditis 18. Pectus excavatum (clinically defined by treating physician) 19. Severe scoliosis 20. Pregnancy or desire to get pregnant within the next 12 months. 21. LVEF \< 30% 22. Current participation in a clinical investigation that involves an active treatment arm. 23. Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study 24. 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 |
|---|---|---|
| Percent of subjects with complete exclusion | 90 days | To assess the rate of complete exclusion of the LAA measured by color duplex TEE at 4 time points: Acute (i.e., immediately after LAA exclusion procedure), 1 day, 1 month, and 3 month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Exploratory objectives of procedural success and device-related complication rates | 3 month | * The rate of procedural success * The rate of complications related to the use of the LARIAT RS and accessories |
Countries
Poland
Outcome results
None listed