Premium
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
Author(s) -
HildickSmith David,
Diener HansChristoph,
Schmidt Boris,
Paul Vincent,
Settergren Magnus,
Teiger Emmanuel,
Camm John,
Tondo Claudio,
Landmesser Ulf
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27252
Subject(s) - medicine , atrial fibrillation , left atrial appendage occlusion , occlusion , stroke (engine) , catheter , prospective cohort study , cardiology , surgery , warfarin , mechanical engineering , engineering
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.