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Biosense Webster – Ongoing Studies
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.
STELLAR Study
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)
Design and objective: Prospective, multicenter, single-arm study to determine the safety and 12-month effectiveness of the multielectrode radiofrequency balloon catheter for the treatment of drug-refractory paroxysmal atrial fibrillation.
Q-FFICIENCY Study
Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation in Subjects With Paroxysmal Atrial Fibrillation (Q-FFECIENCY)
Design and objective: Prospective, nonrandomized, premarket clinical evaluation to demonstrate the safety and effectiveness of the QDOT MICRO™ Catheter compared with a historical control performance goal in subjects undergoing electrophysiology mapping and radiofrequency ablation for treatment of drug-refractory, symptomatic paroxysmal atrial fibrillation.
VISITAG SURPOINT™ US POSTAPPROVAL Study
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Design and objective: Prospective, nonrandomized, postmarket clinical evaluation to determine the 12-month effectiveness of Tag Index-guided ablation using the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters with VISITAG SURPOINT™ Module with EPU for pulmonary vein isolation in the treatment of drug-refractory, symptomatic paroxysmal atrial fibrillation.
WAVECREST2 Study
WaveCrest Vs. Watchman TranssEptal LAA Closure to Reduce AF-Mediated Stroke 2 (WAVECREST2)
Design and objective: Prospective, multicenter, randomized, active control study of the Coherex WaveCrest™ Left Atrial Appendage (LAA) device compared to the Watchman® LAA device for the reduction in risk of ischemic stroke or systemic embolism in subjects with nonvalvular atrial fibrillation who seek a nonpharmacologic alternative to chronic oral anticoagulation.