Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.

Official Title
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Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Implantation of LAA closure device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented paroxysmal, persistent or chronic non-valvular AF Calculated CHA2DS2 -VASC score equal or greater than 2 and/or HAS-BLED score equal or greater than 2 Patients eligible or non-eligible for lifelong, oral anticoagulation therapy Life expectancy of at least 1 year Written, informed consent by the patient or her/his legally-authorized representative for participation in the study Exclusion Criteria: Suspected or known intracardiac thrombus NYHA Class IV CHF Patients who has unstable and intractable angina pectoris ASD and/or atrial septal repair or closure device Recent myocardial infarction within 3 months Severe valvular heart disease, or implanted mechanical valve prosthesis Large PFO with significant atrial septal aneurysm Planned ablation procedure within 30 days of Occlutech LAA occluder® implant Resting heart rate > 110 bpm Allergy to Nitinol, which is a result of nickel and/or titanium allergies Stroke/TIA within the last 30 days Thrombocytopenia, thrombocytosis, leukopenia, or anemia Symptomatic carotid artery disease LVEF < 30% Mitral valve stenosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAA closure device<br>Implantation of LAA closure device | Device: Implantation of LAA closure device<br> <br> * Other names: Occlutech LAA occluder in different sizes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful implantation of the Occlutech LAA closure device with less than 7% occurrence of major complications. | A major complication is defined as an event that results in death, procedure related stroke, systemic embolism, device embolisation, pericardial effusion (cardiac tamponade), or other major bleeding requiring invasive treatment or blood transfusions. | 12 months |