Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: LARIAT Suture Delivery Device and Accessories


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 21 years Diagnosed non-valvular atrial fibrillation Current CHADS2 score > 2 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). Life expectancy of at least 1 year Willing and able to return and comply with scheduled follow up visits Willing and able to provide written informed consent Exclusion Criteria: Prior 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 within last 3 months 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 within the last 30 days Transient ischemic attack (TIA) within the last 30 days Current diagnosis of active systemic infection eGFR < 60 mL/min/1.73m2 within last 3 months Current renal failure requiring dialysis 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) 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 Thrombocytopenia (platelet count < 100 x 109/L) based on most recent pre-procedure assessment (within 30 days of study treatment) Anemia with hemoglobin concentration of < 10 g/dL based on most recent pre-procedure assessment (within 30 days of study treatment) Pregnancy or desire to get pregnant within next 12 months. Current enrollment in an investigation or study of a cardiovascular device or investigational drug that would interfere with this registry 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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAA exclusion with LARIAT & Accessories<br>Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories | Device: LARIAT Suture Delivery Device and Accessories<br> <br> * Other names: TENSURE Suture Puller;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete exclusion | 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). | During 1 year follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Atrial Appendage, LARIAT, atrial fibrillation, contraindication to oral anticoagulation therapy