Medtronic has announced the commencement of a new study assessing its cryoablation technology as a means of treating persistent atrial fibrillation.
The first patients have now been enrolled in the STOP Persistent AF clinical trial, which aims to evaluate the safety and effectiveness of a pulmonary vein isolation-only treatment strategy using the Arctic Front Advance cardiac cryoablation catheter.
“Medtronic has commenced a new clinical trial assessing the performance of its Arctic Front Advance cardiac cryoablation catheter in the treatment of atrial fibrillation.“
Up to 225 patients will be enrolled at 25 centres across the US, Canada, Europe and Japan, with subjects to be followed for 12 months after the initial cryoballoon ablation procedure.
Persistent atrial fibrillation occurs when the upper chambers of a patient's heart beat erratically for more than seven days, requiring medical intervention and drug therapy to stop the episode. These individuals experience an elevated risk of stroke and heart failure.
Colleen Fowler, vice-president and general manager of Medtronic's atrial fibrillation solutions business, said: "According to a study in JAMA, the number of patients with atrial fibrillation 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."
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