Evaluation of the Sphere-9 Catheter and Affera Ablation System in Adults Undergoing Redo Ablation for Recurrent Paroxysmal or Persistent Atrial Fibrillation

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the Sphere-9 Catheter and Affera Ablation System in adults with symptomatic recurrent paroxysmal or persistent atrial fibrillation who have previously undergone a single ablation procedure. The study is prospective, multi-center, and non-randomized, enrolling up to 400 subjects across the United States, Europe, and Australia. It focuses on patients experiencing recurrent symptoms after their initial ablation treatment. Participants will receive a redo atrial fibrillation ablation procedure using the Sphere-9 Catheter combined with the Affera Ablation System and Affera Mapping System. This device-based procedure delivers radiofrequency and pulsed field energy following the study protocol. All subjects receive the same intervention without a control group. The study includes a 12-month follow-up period after the redo ablation procedure. During the study, participants will be monitored at 7 days, 3 months, 6 months, and 12 months after the procedure, including evaluations such as a 24-hour Holter monitor at the final visit. Researchers will measure treatment success and monitor for safety events up to 12 months post-procedure. The expected duration of the entire study is approximately two years, covering about one year of enrollment and one year of follow-up for each participant.

Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)