September 1, 2017Catheterization and Cardiovascular Interventions10 citations
Rationale and design of a global registry to evaluate real‐world clinical outcomes in patients with atrial fibrillation and high risk of stroke treated with left atrial appendage occlusion using the AMPLATZER amulet device—Perspective of available/ongoing registries of catheter‐based LAA occlusion
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Key Result
The Global Amplatzer Amulet LAA registry will prospectively evaluate the safety and efficacy of catheter-based LAA occlusion in 1,000 patients with atrial fibrillation followed for 2 years.
Study Design
Type
Observational (n=1,000)
Multicenter
Yes
Structured PICO
What are the real-world peri-procedural and long-term clinical outcomes of catheter-based LAA occlusion using the AMPLATZER Amulet device in patients with atrial fibrillation?
P
Population
1,000 all-comer patients with atrial fibrillation undergoing catheter-based LAA occlusion for stroke prevention, followed for 2 years.
E
Exposure
Catheter-based left atrial appendage (LAA) occlusion using the second generation AMPLATZER Amulet LAA occlusion device
O
Outcome
Procedural and long-term data on ischemic stroke, systemic embolism, cardiovascular death and major bleedinghard clinical
The Global Amplatzer Amulet LAA registry is designed to provide prospective, real-world data on the safety and efficacy of the second-generation AMPLATZER Amulet device for stroke prevention in patients with atrial fibrillation.
Abstract
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.