Medtronic has announced enrolment completion and final treatment in the SPHERE Per-AF, a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. The study aims to evaluate the safety and efficacy of the Sphere-9 pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform to treat persistent atrial fibrillation (AF).
Designed to improve efficiencies by utilising HD mapping, the Medtronic technology is used to diagnose arrhythmias and provide treatment for patients with a single catheter. By combining navigation, mapping and therapeutic capacities, the Sphere-9 catheter can deliver both RF and PF energies for ablation, enabling physicians to tailor treatment on the basis of patients’ requirements during ablation.
The Sphere Per-AF trial is a prospective, randomised and multicentre clinical trial, including 477 patients enrolled since December 2021 with persistent AF across 23 centres in the USA and Europe. Patient assessments will span across 12 months measuring safety and effectiveness.
“During the trial, my observations and experience with the novel Affera system have been very promising,” comments Devi Nair (St Bernards Medical Center, Arkansas, USA), continuing: “Unlike conventional technologies, I have been impressed with the ability to both map and ablate with the option of dual energy sources, with one catheter. I look forward to the results of the trial and remain optimistically enthusiastic as I continue to understand the safety and efficacy of the Sphere-9 ablation catheter.”
Reflecting on the progress of the trial since its inception, Rebecca Seidel, president of Cardiac Ablation Solutions business at Medtronic, notes: “Treating the final patient in the fast-moving SPHERE Per-AF trial builds on the exciting phase of innovation and growth at Medtronic over the last year, including the acquisition of Affera, our agreement to distribute a differentiated portfolio of left-heart access tools and devices to support a zero-exchange procedure workflow, and the continued progress in the development of PulseSelect, our organic PFA system.” She adds: “Thanks to the innovation and expertise within Affera and the support of our Medtronic team, together we are able to continue to evaluate new, best-in-class solutions and commercialise a full, comprehensive portfolio to help physicians treat patients around the world.”