Irish medical technology firm Medtronic has enrolled th first patient in the Gold AF Registry trial to assess Radiofrequency (RF) Ablation technology to treat patients with symptomatic atrial fibrillation (AF).
The multicenter registry will offer 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 include firm’s Phased RF technology.
The Medtronic Phased RF System is a new endocardial catheter system, which provides customized RF energy to eliminate or block abnormal electrical impulses in the left atrium that initiate or sustain AF.
Netherlands St. Antonius Ziekenhuis Nieuwegein cardiologist Dr Boersma said: "The Gold AF Registry will give us the opportunity to further evaluate and uncover best practices for treating patients with Phased Radiofrequency technology."
The Gold AF Registry will evaluate treatment by PVAC GOLD ablation of patients with paroxysmal (occasional) or persistent AF, lone AF or AF with underlying disease, and provide data on acute and mid-term success rates and other procedural details and patient characteristics.
The trial will enroll up to 1,000 patients at 50 sites in 11 countries, including Belgium, France, Germany, Greece, Israel, Italy, the Netherlands, Poland, Spain, Switzerland and the UK.
Principal Investigators for the study include Dr Boersma and Dr Mèléze Hocini and patients will be observed for 12 months following a Phased RF procedure.