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Medtronic Presents STOP AF Pivotal Trial Findings

Medtronic has released new STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial data showing the number of paroxysmal atrial fibrillation (AF) patients reporting AF symptoms declined by 80% after treatment with the Arctic Front Cardiac CryoAblation Catheter System.

As reported in the quality-of-life questionnaire (SF-36) results, all patients randomized and treated with the Medtronic Arctic Front Cardiac CryoAblation Catheter System reported significant improvement in physical and mental quality-of-life factors when compared to baseline measurements (P<0.001).

According to the Medtronic, the number of patients randomized to cryoablation in the STOP AF trial who reported AF symptoms declined from 100% at baseline (pre-treatment) to 20% at 12 months after cryoablation treatment.

Specifically, when compared at baseline and 12 months, there was a reduction in the number of study participants who reported the six symptom categories that include: palpitations (86 to 25%), fatigue (76 to 13%), rapid heart beat (66 to 16%), dyspnea, or difficulty breathing (54 to 9%), dizziness (48 to 9%), and syncope, or fainting (4 to 1%). To some AF patients, these symptoms can be debilitating.

The CryoAblation System is commercially available for use in Europe; however, it is under investigational use in the US.

The STOP AF pivotal clinical trial enrolled 245 patients at 26 US and Canada centers and studied the safety and effectiveness of the Medtronic Arctic Front Cardiac CryoAblation Catheter System in paroxysmal AF patients as compared to drug therapy.

All primary safety and effectiveness endpoints in the trial were met. These results are part of the PMA submission under regulatory review by the US FDA approval for the CryoAblation System.

The Medtronic Arctic Front Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional mapping systems.

The technologies used in the STOP AF trial include: the Arctic Front Cryocatheter, which inflates and fills with coolant to ablate the tissue where the pulmonary veins enter the left atrium; the FlexCath Steerable Sheath, which helps deliver and position the cryocatheter in the left atrium; the Freezor MAX Cardiac CryoAblation Catheter, which is a single-point catheter used to provide additional ablations, as needed; and the CryoConsole, which houses the coolant, electrical and mechanical components that run the catheters during a cryoablation procedure.

The Arctic Front Cardiac CryoAblation Catheter System uses cryoablation, or freezing technology. A coolant is released into the catheter’s balloon to freeze and ablate the tissue; freezing helps the balloon maintain contact with the tissue. To date, more than 9,000 patients have been treated globally with the Arctic Front Cryocatheter.

Jeremy Ruskin, chair of the STOP AF trial steering committee, director of cardiac arrhythmia service at Massachusetts General Hospital and associate professor of Medicine at Harvard Medical School in Boston, said: “The significant reduction in AF-related symptoms observed in this trial demonstrates the potential relief that cryoablation therapy can provide to patients suffering from symptomatic paroxysmal AF.”