Medtronic has announced the first patient enrolment in the GOLD AF registry, a first-of-its-kind, prospective, observational clinical study of its Phased Radiofrequency (RF) Ablation technology for treating patients with symptomatic atrial fibrillation.
The first patient was enrolled at St Johannes Hospital, Dortmund, Germany, by Iskandar Djajadisastra.
The multicentre registry will provide real-world insights into the procedural use and treatment outcomes of the Pulmonary Vein Ablation Catheter (PVAC) Gold, multi-electrode ablation catheter and other catheters that comprise Medtronic’s Phased RF technology.
The Medtronic Phased RF System, according to a company release, has been used to treat more than 30,000 patients and is approved in areas of Europe, Asia, South Africa, Australia and Canada. The system is not approved in the United States, but is under IDE study in the VICTORY AF clinical trial.
“The GOLD AF registry will give us the opportunity to further evaluate and uncover best practices for treating patients with Phased Radiofrequency technology,” says LV Boersma from St Antonius Ziekenhuis Nieuwegein, The Netherlands. “We will be able to review data- in a very large patient cohort-on the PVAC Gold catheter, which maps, ablates and validates pulmonary vein isolation quickly. Pulmonary vein isolation is a clinically effective therapy for treating symptomatic atrial fibrillation patients, and the goal of the PVAC Gold catheter is to allow physicians to effectively isolate the veins.”
About the GOLD AF registry
The GOLD AF Registry will assess treatment by PVAC Gold ablation of patients with paroxysmal or persistent atrial fibrillation, lone atrial fibrillation or atrial fibrillation with underlying disease, and provide data on acute and mid-term success rates, as well as other procedural details and patient characteristics. It will enrol up to 1,000 patients at 50 sites in 11 countries: Belgium, France, Germany, Greece, Israel, Italy, The Netherlands, Poland, Spain, Switzerland and the United Kingdom. Patients will be observed for 12 months following a Phased RF procedure.