ASA Plavix Feasibility Study With WATCHMAN Left Atrial Appendage Closure Technology

Boston Scientific Corporation150 enrolled

Overview

The purpose of the study is to characterize the performance of the WATCHMAN LAA Closure Device in atrial fibrillation patients for which long term warfarin therapy is contraindicated.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

150

Conditions

Atrial Fibrillation

Interventions

WATCHMANDEVICE

WATCHMAN LAA Closure Device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age or older * paroxysma, persistent, or permanent non-vlavular atrial fibrillation * contraindicated to warfarin * eligible for clopidogrel, ticlopdine, heparin, or aspirin * CHADS score 1 or greater Exclusion Criteria: * NYHA Class IV * LAA obliteration * Heart transplant * LVEF less than 30% * greater than 50% carotid stenosis

Locations (4)

NA Homolce Hospital

Prague, Czechia

Sankt Katharinen Hospital / Cardiovasculares Centrum

Frankfurt, Germany

Herzzentrum Leipzig

Leipzig, Germany

Chefarzt der Medizinischen Klinik III/Kardiologie

Regensburg, Germany

Outcomes

Primary Outcomes

Feasibility study to characterize the performance of the WATCHMAN LAA Closure device in atrial fibrillation patients contracindicated to warfarin treatment

Time frame: 2 years

Data from ClinicalTrials.gov

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