The 225-patient, 12-month trial aims to explore the effectiveness and safety of pulmonary vein isolation-only treatments for patients with persistent atrial fibrillation using the Arctic Front Advance cryoablation catheter, the Fridley, Minn.-based company said.
The 1st patient in the trial was treated by Dr. John Harding at Doylestown, Penn.’s Doylestown Hospital, the company said.
“Gaining meaningful data from this trial will help further clinicians’ understanding of possible treatment options for patients with persistent AF. As AF progresses and episodes become more constant, patients’ quality of life diminishes while their risk of AF-related health effects, such as heart failure and stroke, increases. This trial could help us advance care for this hard-to-treat population,” co-principal investigator Dr. Hugh Calkins of Baltimore’s Johns Hopkins Hospital said in a prepared statement.
Medtronic said that recently updated guidelines from the European Society of Cardiology supported cryoablation therapy for treating AF, and supported PVI as an effective and preferred treatment for select patients with AF.
“According to a study in JAMA, the number of patients with AF is expected to double in the next couple of decades and we want to ensure that physicians are equipped with the most innovative approaches and treatments. We hope this study leads to greater insights that can improve care for patients with persistent AF,” AF solutions biz GM Colleen Fowler said in a press release.