Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation

Study Overview
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Brief Summary
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Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation. However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy. Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated. The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected. TEE will be performed at three and six months to check for device leak, displacement and thrombosis.

Official Title
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Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: left atrial appendage occluder implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with paroxysmal/persistent/permanent atrial fibrillation CHA2DS2VASc score ≥2 for male and ≥3 for female Without contraindications to anticoagulation therapy Exclusion Criteria: LAA thrombosis mechanical prosthetic heart valve moderate or severe mitral valve stenosis

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: left atrial appendage occluder implantation|all patients will get implantation of LAA occluder|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Composite of death, stroke, clinically significant bleeding event (>_2 class according to BARC criteria), device leak, device displacement or device thrombosis with the first event for a given patient is taken into account | a clinically significant bleeding event is >_2 class according to Bleeding Academic Research Consortium (BARC) criteria bleeding | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device thrombosis during first 6 months | device thrombosis detected by transesophageal echocardiography during first 6 months of follow-up | 6 months | 
| device dislocation | number of patients who would have device dislocation | 36 months | 
| any bleed | total number of patients who would have any bleeding event | 36 months | 
| bleeding BARC ≥2 | total number of patients who would have bleeding event with the grade BARC ≥2 | 36 months | 
| device leak and displacement during first 6 months | device leak detected by transesophageal echocardiography during first 6 months after implantation or device displacement during the same time period | 6 months | 
| any adverse events during 7 days after LAA occluder implantation | any adverse events related to the device implantation during the first 7 days after implantation | 7 days | 
| change in QOL SF 36 between baseline and final visit | change in quality of life (QOL) by Short Form (SF) 36 Health Survey between baseline and follow-up visits SF 36 is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health. 0-100 scale are using to access each domain. lower the score the more disability. | Assessed at baseline and 6-month follow-up visits | 
| the percent of patients in whom long -term anticoagulation therapy would add during follow-up | number of patients who would require adding permanent anticoagulant therapy for any reason during follow-up | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left atrial appendage, LAA occluder, thromboembolic prophylaxis, atrial fibrillation