First Patient Enrolled in U.S. LAA Stroke Study

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22/01/2018

Heart Arrhythmia specialist, J&J company, Biosense Webster, Inc. has enrolled the first patient in a study to evaluate the safety and effectiveness of a pioneering Left Atrial Appendage (LAA) closure treatment.

The Biosense Webster, Inc. WaveCrest® Left Atrial Appendage Occlusion (LAAO) System is designed used for closure of the LAA. Ostensibly a safety and effectiveness study, WaveCrest will also evaluate reduction of embolic stroke in atrial fibrillation (AFib) patients who cannot tolerate chronic Oral Anticoagulation Therapy (OAC).

The study is a prospective, multicenter, randomized, active controlled clinical trial of the WaveCrest® Left Atrial Appendage Occlusion System compared to an existing FDA-approved LAA Closure Device for the reduction in risk of embolic stroke in subjects with non-valvular atrial fibrillation.

The first patient was treated at New York University (NYU) Hospital by Larry Chinitz, MD, a cardiac electrophysiologist and director of NYU Langone’s Heart Rhythm Center in New York City. The trial will enroll 1,250 patients at approximately 90 hospitals, and follow them for five years.


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