The objective of this trial is to compare two different commercially available left atrial appendage occlusion (LAAO) devices in patients with non-valvular Atrial fibrillation/ atrial flutter (AF) at increased risk for stroke with regard to safety and efficacy.
The investigators hypothesize that LAAO using the LAmbre occlusion device (Lifetech Scientific, Shenzhen, China) is non-inferior to LAAO using the AMPLATZER Amulet occlusion device (Abbott Medical, Chicago, ILL, USA) with regards to the primary endpoint, which is peri-device leak (PDL) size 3 months after LAAO, as assessed with transesophageal echocardiography (TOE) in patients with non-valvular AF.
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
Indication for long-term oral anticoagulation therapy for a condition other than AF (i. e. pulmonary embolism, mechanical heart valve)
LAA is obliterated or surgically ligated
Known allergy or hypersensitivity to any component of the LAAO devices or components of the required medication regimen
Prior atrial septal defect (ASD) repair or implantation of ASD closure device
Parallel
Left Atrial Appendage Occlusion
DeviceLeft Atrial Appendage Occlusion will be performed according to current international standards by experienced operators under TOE and angiographic guidance. Either a LAmbre occlusion device (group A) or an AMPLATZER Amulet occlusion device (group B) will be implanted depending on treatment allocation.
PDL size after 3 months
Peri-device leak size (in mm) three months after successful LAAO as assessed with TOE.
Device Sucess
Defined as device deployed and implanted in correct position.
Procedural Duration
End time (closing of X-Ray) minus start time (access site puncture).
Technical success
Defined as exclusion of the LAA with residual peri device leak size ≤ 5mm and no device-related complications during index hospitalization.
Procedural success
defined as technical success with no procedure-related complications, except for uncomplicated (minor) device embolization
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Deutsches Herzzentrum Muenchen
Lead sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
Collaborator
