New PFA registry will use AI, EHR integration to gather real-world data
The Heart Rhythm Society (HRS) has announced a new registry for collecting and storing real-time data on patients who undergo pulsed field ablation (PFA) to treat atrial fibrillation (AFib). To minimize the burden of data entry, the registry will use advanced artificial intelligence algorithms and direct electronic health record integration that automatically fill in certain details for the clinician once a PFA procedure has been completed.
PFA uses high-voltage electrical pulses to treat paroxysmal and persistent atrial AFib, as opposed to the heat and cold used by radiofrequency ablation and cryoablation, respectively. PFA is consistently linked to positive patient outcomes and a superior safety profile, and it has emerged as the preferred ablation strategy for a growing number of electrophysiologists. However, questions remain about PFA’s long-term impact. For instance, could it be associated with side effects years from now that have not yet been identified?
HRS sees its new registry as a way to help answer those long-term questions about PFA. In addition, the real-time data will help cardiologists research best practices and learn which patients benefit the most from undergoing PFA. These data can even be used to help companies receive FDA approvals and other regulatory milestones.
“The development of the HRS PFA data collection platform represents a turning point in how we study and treat AFib,” HRS President Mina K. Chung, MD, a Cleveland Clinic cardiologist, said in a statement. “By combining cutting-edge technology with a national infrastructure, we are creating opportunities to not only reduce the burden on clinical sites but also deliver regulatory-grade evidence needed to guide innovations, inform policy, and improve patient care. This initiative will ensure that every procedure contributes to a deeper understanding of AFib and helps shape the future of cardiac care.”
Johnson & Johnson MedTech, one of the many vendors in a the growing PFA market, has signed on as an official sponsor of the HRS registry. The company's Varipulse PFA platform gained U.S. Food and Drug Administration approval in November 2024 and CE mark approval in February 2024. It has also gained regulatory approvals in Asia Pacific, Canada and Latin America.
“This effort reflects our long-standing commitment to partnering with the clinical community and strengthening scientific understanding, a dedication grounded in our decades of scientific expertise and leadership in electrophysiology,” Michael Bodner, chair of electrophysiology and neurovascular technologies at Johnson & Johnson MedTech, said in the same statement.
The new registry is expected to go live in early 2026. Full-scale implementation is expected in 2027.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.