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Ongoing Studies
Ongoing Studies
Biosense Webster, Inc. partners with leading physicians globally to conduct clinical studies to evaluate novel technologies for the treatment of complex heart rhythms and conditions.
MEDIA
Biosense Webster, Inc. partners with leading physicians globally to conduct clinical studies to evaluate novel technologies for the treatment of complex heart rhythms and conditions.
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.
The THERMOCOOL SMARTTOUCH™ SF Dual Energy Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory bodies in any market.
afIRE Study
A Study of Multi-Electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (afIRE)
Design and objective: Prospective, multicenter, single-arm study to demonstrate the safety and long-term effectiveness of the BWI IRE ablation system (VARIPULSE™ Catheter and 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.
The VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory bodies in any market.
admIRE Study
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (admIRE)
Design and objective: Prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the BWI IRE ablation system (VARIPULSE™ Catheter and 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.
The VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory bodies in any market.
inspIRE Study
A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE)
Design and objective: Prospective, multi-center, single-arm study to demonstrate the safety and long-term effectiveness of the IRE system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins in treatment of participants with symptomatic, drug refractory paroxysmal atrial fibrillation.
The VARIPULSE™ Catheter and TRUPULSE™ Generator are currently investigational and are not approved by regulatory bodies in any market.
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.
The CLARYSENSE™ Catheter is currently investigational and are not approved by regulatory bodies in any market.
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.