"Enrolling the first patient in this important study for a new technology that advances options for AFib is an exciting opportunity for our team and for patients,” said Jay Sengupta, MD, electrophysiologist and director of the Joseph F. Novogratz Family Heart Rhythm Center at the Minneapolis Heart Institute Foundation, and the principal investigator for the Horizon 360 clinical trial.
This new technology is designed to minimize the steps and time involved in addressing the cause of the AFib, while better protecting nearby structures, which is innovation that is meaningful for patients and clinicians. We are proud to be part of the research advancing this technology.
The completion of this landmark first case places MHIF and the Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital among a select group of leading research centers participating in the Horizon 360 Investigational Device Exemption (IDE) pivotal trial and makes Minnesota the newest state to join this pioneering research effort.
AFib is the most common cardiac arrhythmia, affecting at least 10.5 million American adults, a number projected to reach 12.1 million by 2050. It is associated with a fivefold increased risk of ischemic stroke and contributes to more than 158,000 deaths in the United States each year.
Unlike traditional ablation approaches, PFA uses precisely targeted high-voltage electrical impulses to treat tissue around the pulmonary veins – the areas of the heart most AFib originates. PFA is non-thermal and leverages a phenomenon called irreversible electroporation which is uniquely selective to heart muscle cells. This means it can treat the tissue causing AFib while preserving surrounding structures including nerves, blood vessels, and the esophagus.
The Sphere-360™ catheter, developed by Medtronic, is a first-of-its-kind, all-in-one mapping and single-shot PFA catheter, meaning it maps, ablates, and validates through a single catheter, in a single procedure. What sets the Sphere-360™ PFA catheter apart is a conformable, adjustable lattice tip shaped like a sphere that expands to fit around the patient’s pulmonary vein anatomy to deliver a complete ablation area with no catheter rotation required. The catheter is fully integrated with Medtronic's Affera™ Mapping and Ablation System, providing real-time navigation and mapping for the ablation.
This milestone is consistent with MHIF's long legacy of leading cardiovascular innovation. In 1981, MHIF founder Dr. Robert Van Tassel performed the first coronary balloon angioplasty in Minnesota. In January 2025, MHIF physician researchers – led by electrophysiologist Dr. Jay Sengupta – performed the first procedure in Minnesota and the upper Midwest using the Affera™ Mapping and Ablation System with Sphere-9™ Catheter, a related Medtronic platform for persistent AFib. Now, with first Sphere-360™ case in Minnesota, MHIF continues its commitment to leading heart rhythm research and patient care.
The Horizon 360 IDE trial is a prospective, single-arm, pre-market clinical study enrolling up to 300 subjects at up to 26 sites across the United States. MHIF is proud to be an enrolling site with Dr. Sengupta as principal investigator, Edwin Zishiri, MD, as co-investigator, and the research team, including Julianne Feola, PhD, Efrah Hussein, Rachel Roisum, and Dawn Witt, PhD, MPH.
Paroxysmal AFib comes and goes, often without warning. The irregular heartbeat, fatigue, breathlessness, and anxiety that accompany AFib episodes can dramatically diminish quality of life and bring an elevated risk of stroke.
This research underway at MHIF is a critical step toward making this technology available to AFib patients everywhere. In January 2026, Medtronic simultaneously announced CE Mark approval in Europe and the first cases at multiple U.S. sites in the Horizon 360 IDE trial. MHIF is proud to be among those sites and to have performed the first case in the state of Minnesota.
The Sphere-360™ PFA catheter is an investigational device and is a trademark of Medtronic. Affera™ is also a trademark of Medtronic.
For more information about MHIF's heart rhythm research programs or to learn about clinical trial participation, visit mplsheart.org/heart-rhythm.
