Safety and Efficacy Study of LAmbre LAA Closure Device for Treating AF Patients Who Cannot Take Warfarin

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy, safety and performance of LAmbre left atrial appendage closure system in patients with non-valvular atrial fibrillation who cannot be treated with Warfarin.

Official Title
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Evaluation of Safety and Efficacy of the New Generation of Left Appendage Closure With the LAmbre Device in AF Patients Not Suitable for Use of Warfarin

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: LAA closure system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=18, CHADS2 score>=1 Patients cannot be treated long-term with Warfarin Eligible for clopidogrel and aspirin Provide written informed consent and agree to comply with required follow-ups Exclusion Criteria: Need to take Warfarin Presence of rheumatic, degenerative or congenital valvular heart diseases Early stage or paroxysmal AF Symptomatic patients with carotid artery disease (such as carotid stenosis>=50%) Heart failure NYHA grade IV Recent 30 days stroke or TIA Presence of active sepsis or endocarditis Cardiac tumors or other malignancy with estimated life expectancy <2 years Abnormal blood test; renal disfunction LAA removed or heart implant patients Patients have planned electrophysiological ablation or cardioversion 30 days post implantation of the LAmbre system Patients have history of mechanical prosthesis operation Patients who are pregnant, or desire to be pregnant during the during the study Participation in other trials A known allergy to nitinol Patients will not be able to complete the trial Esophageal ultrasonic exclusion criteria: LAA Ostium <=12mm or >=30mm LVEF <30% Presence of thrombus in the heart High risk PFO Mitral valve stenosis (valve area <2 cm2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: LAmbre closure system<br> | Device: LAA closure system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke |  | One year | 
| Successful sealing of the LAA |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Component events | death, thromboembolism, device related complication and MACCE | One year | 
| MACCE | all-cause death, stroke, cardiac tamponade and renal failure | One year | 
| Complication at puncture site |  | One year | 
| Device performance assessed by TEE/TTE | Device migration/embolization Regurgitation Perivalvular leak | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LAmbre