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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.

Identifieur interne : 000516 ( PubMed/Curation ); précédent : 000515; suivant : 000517

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.

Auteurs : David Hildick-Smith [Royaume-Uni] ; Hans-Christoph Diener [Allemagne] ; Boris Schmidt [Allemagne] ; Vincent Paul [Australie] ; Magnus Settergren [Suède] ; Emmanuel Teiger [France] ; John Camm [Royaume-Uni] ; Claudio Tondo [Italie] ; Ulf Landmesser [Allemagne]

Source :

RBID : pubmed:28862376

Abstract

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.

DOI: 10.1002/ccd.27252
PubMed: 28862376

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pubmed:28862376

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<div type="abstract" xml:lang="en">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.</div>
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<ArticleTitle>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.</ArticleTitle>
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<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">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.</AbstractText>
<AbstractText Label="BACKGROUND" NlmCategory="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.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
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