Medtronic commences cryoablation trial for atrial fibrillation

Medtronic has announced the commencement of a new clinical trial assessing a promising new approach to treating atrial fibrillation.

The first patients have been enrolled in the STOP AF First study, which will evaluate the safety and effectiveness of performing pulmonary vein isolation with the Arctic Front Advance Cryoballoon in patients with symptomatic paroxysmal atrial fibrillation prior to treatment with antiarrhythmic medications.

Up to 210 patients will be involved at around 30 US sites, with the aim of establishing the effectiveness of cryoballoon ablation as a means of treating the condition.

Cryoablation is administered via a minimally invasive procedure to isolate the pulmonary veins – a source of erratic electrical signals – with cold energy used to create scar tissue and interrupt irregular electrical pathways in the heart.

About half of patients with symptomatic atrial fibrillation do not respond to antiarrhythmic drugs, meaning there is a clinical need for new therapeutic options.

Colleen Fowler, vice-president and general manager of Medtronic's atrial fibrillation solutions business, said: "With the number of atrial fibrillation patients expected to increase exponentially in the coming years, this trial will help ascertain whether earlier treatment with the cryoballoon can improve outcomes for a greater number of patients."

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