Medtronic (NYSE:MDT) announces clinical trial results from the STOP AF First trial, evaluating the safety and effectiveness of the Arctic Front Advance Cardiac Cryoballoon and Freezor MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation (PAF) compared to anti-arrhythmic drug (AAD) treatment.
Results showed superiority of cryoablation for maintaining freedom from Atrial fibrillation (AF), atrial tachycardia and atrial flutter, with treatment success achieved in 75% of patients in the catheter ablation group versus 45% in the AAD group (P<0.0001). Furthermore, the trial revealed a low rate of safety events with catheter ablation (1.9%).
Additionally, 12-month outcomes from the Cryo-FIRST trial showed a significant improvement in AF-related quality of life with the use of the Medtronic cryoablation system compared to AAD in patients who had not previously received antiarrhythmic drugs to treat their symptomatic PAF.
The STOP-AF First trial enrolled 225 patients, whereas Cryo-FIRST enrolled 220 patients.
Results and findings from both the studies – STOP AF First and Cryo-FIRST – were presented at the European Society of Cardiology (ESC) Congress 2020.
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