LAmbre Versus AMPLATZER Amulet Left AtrIal Appendage Occluder for StRoke ProphylaxIs: The Randomized AMPIRI Trial
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
• 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