Naples FL – March 31, 2025 – The NCH Rooney Heart Institute has successfully completed a clinical trial of the Affera™ Mapping and Ablation System featuring the Sphere-9™ Catheter, a next-generation technology designed to enhance the treatment of atrial fibrillation (AF) and other complex cardiac arrhythmias. NCH is one of only two sites in the state offering this groundbreaking technology. The trial, led by Dinesh Sharma, MD, demonstrated the system’s safety and effectiveness, marking a significant advancement in electrophysiology care.
Affera’s innovative platform integrates high-density mapping with dual-energy ablation capabilities, offering both pulsed field (PF) and radiofrequency (RF) energies. This dual-energy approach allows for more precise, patient-specific treatment, improving outcomes and procedural efficiency.
“We are thrilled to have been part of this groundbreaking trial,” said Dinesh Sharma, MD, electrophysiologist at the NCH Rooney Heart Institute. “The Affera system’s ability to seamlessly combine mapping and dual-energy ablation represents a major step forward in treating patients with persistent AF. Our results showed significant improvements in procedural efficiency and patient recovery, reinforcing NCH’s commitment to offering cutting-edge cardiac care.”
The trial’s success further establishes the NCH Rooney Heart Institute as a leader in advanced heart rhythm treatments and emphasizes the importance of this milestone for both patients and the field of electrophysiology.
“This technology has the potential to redefine how we approach atrial fibrillation treatment,” said Robert Cubeddu, MD, president of the NCH Rooney Heart Institute. “We are proud to have played a role in this clinical trial and to continue our mission of bringing world-class, innovative cardiac care to our community.”
The U.S. Food and Drug Administration (FDA) recently approved the Affera Mapping and Ablation System with the Sphere-9™ Catheter, reinforcing the positive outcomes seen in clinical trials, including those conducted at NCH.
For more information on the NCH Rooney Heart Institute and its commitment to advancing cardiovascular care, visit NCHMD.org.
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