Medtronic, Inc announced completion of a 12-month follow up in the STOP-AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial evaluating the first cryoballoon catheter technology designed to treat paroxysmal atrial fibrillation, the Arctic Front CryoAblation Catheter System. After the study data are analyzed and filed with regulatory authorities, the results will be shared at an upcoming medical meeting. The system is approved for use in Europe, Australia and Hong Kong and is under investigational use in the United States.
The Arctic Front system uses cryoablation, or freezing, to ablate heart tissue between the pulmonary veins and the left atrium. The goal of an ablation is to stop the arrhythmia at the source. During cryoablation, a coolant is released into the catheter’s balloon causing the balloon to freeze and ablate the heart tissue. Freezing helps the balloon maintain contact with the tissue being ablated.
“This catheter is designed to allow physicians to more efficiently and easily ablate than with a single tip ablation procedure,” said Kevin Wheelan, M.D., chief of staff at Baylor Heart and Vascular in Dallas and investigator in the STOP-AF trial. “In this trial, the cryoballoon’s stability simplified the process for these types of cardiac ablation procedures.”
“Arctic Front is one of the tools in Medtronic’s growing AF Solutions portfolio,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division. “Our goal is to develop and deliver breakthrough therapies that help physicians to effectively treat AF patients faster, safer, easier, and with more predictable procedure times.”
STOP-AF is studying the safety and efficacy of the Medtronic Arctic Front CryoAblation Catheter System in paroxysmal AF patients as compared to drug therapy. Patients were randomized to receive ablation therapy or commonly used drug treatments. For every three patients enrolled, approximately two received an ablation and one was randomly assigned to the drug therapy group. Twenty-five US and Canadian centers enrolled 245 patients who were followed for at least 12 months after the ablation procedure. Results will be submitted in consideration for FDA approval for the Medtronic Arctic Front CryoAblation Catheter System.