GOLD AF registry will assess real-world experience with radiofrequency ablation system

Medtronic announced the first patient enrollment in the GOLD AF Registry, a prospective, observational, clinical study of its Phased Radiofrequency Ablation technology for the treatment of patients with symptomatic atrial fibrillation, according to a company press release.

The registry will provide real-world insights into the procedural use and treatment outcomes of the Pulmonary Vein Ablation Catheter GOLD (PVC GOLD), which uses Medtronic’s Phased Radiofrequency Ablation technology.

The Phased Radiofrequency Ablation system is intended to produce radiofrequency energy to block or eliminate abnormal electrical impulses in the left atrium. The PVAC GOLD catheter features nine gold electrodes that deliver radiofrequency energy. According to the release, gold allows for increased thermal conductivity compared to platinum electrodes, improving temperature measurement and power delivery.

The registry will include up to 1,000 patients with paroxysmal or persistent AF enrolled from 50 sites in 11 countries. Participants will undergo phased radiofrequency ablation, with follow-up for 12 months. Evaluated data will include acute and mid-term success rates, patient characteristics and procedural details, according to the release.

“The GOLD AF registry will give us the opportunity to further evaluate and uncover best practices for treating patients with phased radiofrequency technology,” researcher L.V.A. Boersma, MD, PhD, cardiologist at St. Antonius Ziekenhuis Nieuwegein, the Netherlands, said in the release. “Pulmonary vein isolation is a clinically effective therapy for treating symptomatic AF patients, and the goal of the PVAC GOLD catheter is to allow physicians to effectively isolate the veins.”

The phased radiofrequency ablation system is currently approved for use in Asia, Australia, Canada, Europe and South Africa, but not in the U.S.

Disclosure: Boersma is a consultant for Medtronic.