Clinical trial NCT02059707: LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS
Official title: LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS Suture Delivery Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Appendage
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-11
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percent of subjects with complete exclusion
timeFrame: 90 days
Secondary outcomes:
measure: Secondary Exploratory objectives of procedural success and device-related complication rates
timeFrame: 3 month
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Jagiellonian University (John Paul II) Hospilal
Study officials:
References: