August 21, 2024 – NCH Rooney Heart Institute is proud to announce the successful completion of a clinical trial using the novel SPHERE Per-AF technology, a cutting-edge pulse field ablation (PFA) system developed by Medtronic. This groundbreaking treatment for atrial fibrillation (AF) has shown promising results and could potentially revolutionize the management of AF. NCH was one of the country’s few centers to participate in this FDA regulated clinical trial.
SPHERE Per-AF, a state-of-the-art PFA technology, is poised to supplement existing AF treatment methods due to its efficiency, efficacy and safety. Unlike traditional ablation techniques that use thermal energy, PFA utilizes electric pulses to selectively target and ablate cardiac tissue responsible for AF.
NCH was among the few select institutions globally chosen to participate in this prestigious clinical trial. The trial featured both standard and Sphere-9 technology with both demonstrating significant improvements in patient outcomes with a notable reduction in AF recurrence and no major complications. The Sphere-9 catheter was much more efficient with shorter procedure times compared to the current standard treatments.
“We are thrilled with the outcomes we’ve seen using SPHERE Per-AF,” said Dinesh Sharma, MD, section head of Electrophysiology and Lead Clinical Trial Physician at NCH for this study. “This technology represents a major advancement in AF treatment, offering our patients a safer and more effective option.”
Medtronic, a leader in medical technology committed to advancing cardiovascular health through innovative solutions like SPHERE Per-AF, has collaborated closely with NCH throughout the trial. The success of this trial at NCH is a testament to the potential of PFA to transform AF treatment worldwide.
Patients who participated in the trial at NCH have reported high satisfaction with the procedure and recovery process. The positive feedback underscores the potential for widespread adoption of SPHERE Per-AF in clinical practice.
NCH remains dedicated to pioneering advanced medical treatments, cutting-edge research and providing the highest quality care to its patients. For more information on the services of the NCH Rooney Heart Institute, visit http://www.nchheart.com.
About NCH
NCH (Naples Comprehensive Health) is an Advanced Community Healthcare System™ serving Southwest Florida with premier routine, critical, and specialty care. NCH, a locally governed non-profit, is recognized as one of Healthgrades America’s Top 100 Hospitals which puts it in the top 2% in the nation for clinical excellence, in addition to being named a Top 50 Hospital for Surgical Care. The system is more than just two hospitals (referred to as the NCH Baker Hospital and NCH North Hospital) with a total of 713 beds – NCH is an alliance of over 750 physicians and medical facilities in dozens of locations throughout Southwest Florida and is the region’s only Joint Commission accredited Comprehensive Stroke Center. NCH cardiac care is ranked top-3 in the state by Healthgrades. NCH collaborates with the Hospital for Special Surgery for orthopedics, Nicklaus Children’s Hospital for pediatrics, and ProScan Imaging for radiology services, ensuring top-tier medical care is available in Southwest Florida. With the largest provider network, urgent/immediate care centers, diagnostic facilities, and two hospitals, NCH is always advancing the quality of care near you. For more information, visit www.NCHmd.org.
