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

Study Overview
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Brief Summary
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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
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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.

Official Title
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LARIAT RS: An Observational Study of the Performance and Safety of the LARIAT RS Suture Delivery Device

Conditions
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Atrial Appendage

Intervention / Treatment
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* Device: LARIAT RS Suture Delivery Device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAA exclusion procedure<br>LAA exclusion with the LARIAT RS Suture Delivery Device | Device: LARIAT RS Suture Delivery Device<br>* LARIAT RS Suture Delivery Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with complete exclusion | 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Exploratory objectives of procedural success and device-related complication rates | The rate of procedural success The rate of complications related to the use of the LARIAT RS and accessories | 3 month |