Trial Parameters
Brief Summary
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months) 2. Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD) 3. Patient is ≥ 18 years of age 4. Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System 5. Patient is willing and able to comply with study requirements and give informed consent Exclusion Criteria: 1. Long-standing persistent AF (continuous AF sustained \>12 months) 2. Prior left atrial catheter or surgical ablation 3. Life expectancy \<36 months 4. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 5. Current or anticipated participation in any other clinical trial of a drug, device or biologic durin