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)
Medtronic Cardiac Ablation Solutions
Summary
Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia. Subjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.
Description
The Conquer-AF study is a prospective, multi-center, interventional, non-randomized clinical study to evaluate the safety and effectiveness of the Sphere-9 Catheter and Affera Ablation System, when used in conjunction with the Affera Mapping System or Affera Integrated Mapping System, in patients undergoing redo ablation for symptomatic recurrent paroxysmal or persistent atrial fibrillation following a single prior ablation procedure. This study will enroll up to 400 subjects diagnosed with symptomatic recurrent PAF and PsAF and will be conducted at up to 30 study sites located across the Uni…