NCH Rooney Heart Institute Leads Successful Clinical Trial for Groundbreaking Cardiac Ablation Technology

by Paul Hiltz, NCH President & CEO

I am excited to announce that the NCH Rooney Heart Institute has achieved a significant milestone with the successful completion of a clinical trial evaluating the Affera™ Mapping and Ablation System, featuring the Sphere-9™ Catheter.

As one of only two sites in Florida to offer this innovative technology, NCH continues to lead the way in advancing cardiac care.

Designed to enhance the treatment of atrial fibrillation (AF) and other complex cardiac arrhythmias, the Affera system integrates high-density mapping with dual-energy ablation capabilities. By offering both pulsed field (PF) and radiofrequency (RF) energies, the platform allows for precise, patient-specific treatment that improves outcomes and procedural efficiency.

Led by Dinesh Sharma, MD, the trial demonstrated the system’s safety and effectiveness, representing a major advancement in electrophysiology care. The Affera system’s ability to seamlessly combine mapping and dual-energy ablation has proven to be a transformative tool for treating patients with persistent AF. The results showed notable improvements in procedural efficiency and faster recovery times, further solidifying NCH’s commitment to providing cutting-edge cardiovascular care.

The recent approval of the Affera Mapping and Ablation System with the Sphere-9™ Catheter by the U.S. Food and Drug Administration (FDA) underscores the positive outcomes observed during clinical trials, including those conducted at NCH.

With this achievement, the NCH Rooney Heart Institute continues to establish itself as a leader in advanced heart rhythm treatments. This milestone not only benefits the local community but also contributes to the broader field of electrophysiology. For more information on the NCH Rooney Heart Institute’s commitment to advancing cardiovascular care, visit NCHMD.org