Persistent Atrial Fibrillation Clinical Trial
Official title:
Repetitive Activation Patterns and Focal Impulses Identification and Ablation in Persistent AF Using the RHYTHMFINDER-192
The primary purpose of this study is to assess the effectiveness of using CARTOFINDER™ maps
created by the RHYTHMFINDER-192 catheter and the CARTOFINDER™ Algorithm to terminate
persistent atrial fibrillation (PsAF) to either Normal Sinus Rhythm or Atrial Tachycardia
compared to pulmonary vein isolation (PVI) in treating PsAF. The RHYTHMFINDER-192 catheter is
investigational, while the CARTOFINDER™ system is CE marked in Europe.
All subjects with persistent AF who are scheduled to undergo a clinically indicated ablation
procedure for management of their persistent AF will be the target population for screening.
The study will enroll approximately 40-70 subjects. Subjects will undergo CARTOFINDER™ guided
ablation (CFGA) followed by PVI. Subjects will have follow-up visits at 7 days, 3, 6 and 12
months postprocedure.
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