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Ongoing Studies in EMEA
Ongoing Studies
Biosense Webster, Inc. partners with leading physicians globally to advance the treatment of complex heart rhythm and conditions through clinical research. These trials provide patients with new treatment options that are often not widely available to the public.
SECURE Study
An Observational Post-Marketing Study Using Commercially Approved Biosense Webster, Inc. (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
Design and objective: Prospective, multi-center, observational, post-marketing study to assess acute and long-term safety and performance during routine-use standard cardiac arrhythmia ablation procedures while using commercially approved Biosense Webster, Inc. medical devices.
smartfIRE Study
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) With the THERMOCOOL SMARTTOUCH SF Catheter and TRUPULSE Generator (smartfIRE)
Design and objective: Prospective, multicenter, single-arm study to demonstrate the safety and long-term effectiveness of the BWI IRE ablation system (THERMOCOOL SMARTTOUCH™ SF Dual Energy Catheter with TRUPULSE™ Generator in conjunction with the CARTO™ 3 System) when used for isolation of pulmonary veins in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation.
COSMOS Study
A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter (COSMOS)
Design and objective: Prospective, multi-center, single-arm study to demonstrate the safety and performance of the investigational catheter for intracardiac mapping in the atria and ventricles.