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Sphere-9 PAF China Study

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09-02
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07789925
Lead Sponsor Medtronic Cardiac Ablation Solutions
Conditions Paroxysmal Atrial Fibrillation (PAF)
Enrollment 180 participants
Start Date 2026-09-02
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-27