Objectives: To describe the rationale and design of a global prospective registry on catheter-based left atrial appendage (LAA) occlusion using the second generation AMPLATZER Amulet LAA occlusion device and to provide a comprehensive perspective on available/ongoing registries for catheter-based LAA occlusion.
Background: Given the increasing clinical application of catheter-based LAA occlusion, there is an important need for prospective real-world clinical data regarding this cardiac intervention.
Methods: The Global Amplatzer Amulet LAA registry aims to provide prospective real-world data from an all-comer population of atrial fibrillation (AF) patients undergoing catheter-based LAA occlusion for stroke prevention. This observational, prospective, multicenter registry will provide peri-procedural and long-term clinical outcome data for catheter-based LAA occlusion using a second generation LAA occlusion device. The global registry will enroll 1,000 patients at up to 75 institutions. Patients will be followed for 2 years after implantation. Primary endpoints will report procedural and long-term data on ischemic stroke, systemic embolism, cardiovascular death and major bleeding. The study will involve independent event adjudication and echocardiographic core laboratory evaluation. Long-term follow-up data are expected in 2018.
Results: The Global Amplatzer Amulet LAA registry will collect safety and efficacy information on catheter-based LAA occlusion. Characteristics of available and ongoing catheter-based LAA occlusion registries are described.
Conclusions: There is an important need for prospective real-world clinical data of catheter-based LAA occlusion given the increasing application of this intervention. The present global real-world registry will expand our knowledge on peri-procedural and long-term outcome of catheter-based LAA occlusion using a second generation occlusion device.
Keywords: atrial fibrillation; cardiac catheters; observational studies as topic; stroke.
© 2017 Wiley Periodicals, Inc.