RESEARCH AND CLINICAL TRIALS
Baylor Scott & White Heart and Vascular Hospital – Fort Worth Participates in Left Atrial Appendage Occluder Device Study
AMPLATZER™ AMULET™ LAA OCCLUDER TRIAL ( AMULET IDE )
The Amulet IDE trial is designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder . Study participants will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ( treatment ) or the Boston Scientific WATCHMAN ® LAA closure device ( control ). All enrolled subjects will follow the protocol-required tests and assessments at each scheduled followup visit . The principal investigator is Craig Delaughter , MD , PhD , FACC , FHRS , medical director of electrophysiology at Baylor Scott & White Heart and Vascular Hospital – Fort Worth .
“ This is the first IDE ( FDA mandated study for device approval ) for a percutaneous left atrial occluder device that does not require even temporary oral anticoagulation after implantation . Our goal is to participate in all meaningful IDE studies in the left atrial occluder area , so that our patients have the widest range of options , and so that our implanting physicians become expert in all versions of these devices . Ultimately , there will be many of these devices tested in IDE clinical trials , but only some of them will be granted FDA approval . As our physicians participate in these studies , they will learn which devices may be best for which type of patients . In the long term , I want Baylor Scott & White Heart and Vascular Hospital – Fort Worth to be acknowledged as the best place for this type of work to be done , as we will have access to the broadest range of therapies and the deepest experience with them . Being involved in all of these trials takes a lot of work , but this is the only way to guarantee early access to the most innovative and highest quality technology for our patients .”
– Craig Delaughter , MD , PhD , FACC , FHRS
Principal investigator ; Medical Director , Electrophysiology — Baylor Scott & White Heart and Vascular Hospital - Fort Worth
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