At a glance
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Safety and Effectiveness Evaluation of the OMNYPULSE Catheter With the TRUPULSE Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF)
In Brief
A clinical study evaluating OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator for Atrial Fibrillation. Completed, enrolled 188 participants across 13 sites in 8 countries.
Detailed Summary
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).
Study Details
Timeline
Interventions
Participants will undergo catheter ablation with the PF ablation system consisting of the TRUPULSE generator (delivers PF energy through the study catheter) and the OMNYPULSE bi-directional catheter (indicated for use in catheter-based cardiac electrophysiological mapping \[stimulating and recording\] and, when used with a Generator, for cardiac ablation).