Actively Recruiting
Study of Abbotts Volt Pulsed Field Ablation System and Amulet 2 Device for Treating Atrial Fibrillation with Left Atrial Appendage Occlusion and Rhythm Restoration
Led by Abbott Medical Devices · Updated on 2026-07-13
240
Participants Needed
16
Research Sites
39 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effectiveness of a combined procedure using Abbotts Volt Pulsed Field Ablation PFA System and the Amulet 2 Left Atrial Appendage LAA occluder device in patients with non-valvular atrial fibrillation who need both atrial fibrillation AF ablation and LAA occlusion. The study focuses on patients with symptomatic, recurrent, drug-resistant paroxysmal or persistent AF. Participants will undergo a concomitant procedure involving PVI ablation using the Volt PFA System and implantation of the Amulet 2 device to occlude the left atrial appendage. This combined treatment aims to restore heart rhythm and close the LAA. The procedure is performed once per participant, and the study follows them for safety and effectiveness outcomes. During the study, participants will be monitored through visits up to three months after the procedure. Assessments include evaluating the success of LAA occlusion by measuring peri-device blood flow and tracking any adverse events occurring from implant through seven days post-procedure or hospital discharge. Participants will also follow a medication regimen involving oral anticoagulants for at least 60 days post-procedure followed by single antiplatelet therapy, with safety and adherence monitored throughout the study period.
CONDITIONS
Brief Title
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
Research Team
A
Abeer Madbouly, Ph. D
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