Medtronic completes enrollment in SPHERE Per-AF Trial

Medtronic announced the completion of enrollment and final treatment in the SPHERE Per-AF Trial, a U.S. FDA Investigational Device Exemption pivotal trial designed to evaluate the safety and effectiveness of the first-of-its kind Sphere-9 pulsed field and radiofrequency ablation, and high density mapping catheter with the Affera cardiac mapping and navigation platform for the treatment of persistent atrial fibrillation. The SPHERE Per-AF Trial is a global, prospective, multicenter, randomized clinical trial. Since the trial’s commencement in December 2021, the trial enrolled 477 patients with persistent AF across 23 centers in the U.S. and Europe. Patients will be assessed for 12 months for safety and efficacy.