LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs

Korábbi kezelés

• Prior atrial septal defect (ASD) repair or implantation of ASD closure device
• Participation in a concurrent clinical trial, which may confound the results of this trial

Más betegség

• Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)
• Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen
• Active endocarditis or other infection producing bacteremia
• Significant symptomatic carotid artery disease

Egyéb

• LAA is obliterated or surgically ligated
• Patient cannot adhere to or complete the trial protocol for any reason
  • Or any of the following echocardiographic exclusion criteria:
• Intracardiac thrombus
• Intracardiac tumor
• Existing, clinically relevant circumferential pericardial effusion
• Significant mitral valve stenosis

• Age ≥ 18 years and able to give consent
• Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation/ atrial flutter (AF) at high risk of stroke or systemic embolism defined by CHA2DS2-VASc score ≥ 2 (male) or ≥ 3 (female)
• Patient not eligible for long-term oral anticoagulation therapy
• Deemed suitable for percutaneous LAAO
• Able to comply with the required medication regimen after LAAO device implantation
• Written informed consent
• LAA anatomy can accommodate either a LAmbre or AMPLATZER Amulet LAAO device, as per manufacturer's instruction for use (IFU) (the anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial)
• For women of childbearing potential, negative pregnancy test and agree to use reliable method of birth control during the study