Sphere-9 PAF China Study

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF. The main questions it aims to answer are: Is the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System safe for treating PAF? Does the treatment help keep patients free from atrial fibrillation and other abnormal heart rhythms during the 12 months after the procedure? Participants will: Have their heart rhythm assessed before and after the ablation procedure. Have PAF treated using the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System. Have follow-up visits at 3, 6, and 12 months after the procedure.
Epistemonikos ID: 5d1434786c407f25ca6aaf3171bfebc6315a30cd
First added on: Aug 27, 2026