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)

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

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Sphere-9 Catheter Ablation

  Redo atrial fibrillation ablation performed using the Sphere-9 Catheter in conjunction with the Affera Ablation System and Affera Mapping System. The intervention delivers radiofrequency and pulsed field energy according to the study protocol for treatment of recurrent paroxysmal or persistent AF. All participants receive this device-based ablation procedure.

Locations (30)