Data from the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial shows superiority over anti-arrhythmic drugs
STOP-AF is the first and largest, randomized, controlled clinical trial assessing the effectiveness and safety of the Medtronic Arctic Front® Cardiac CryoAblation Catheter System when used to treat patients with drug refractory paroxysmal atrial fibrillation (PAF). Outcomes on all patients were assessed through 12-months of follow-up.
The Medtronic Arctic Front Cardiac CryoAblation Catheter System is an ablation system that 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. 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 electroanatomical 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.
To date, more than 9000 patients have been treated worldwide with the Arctic Front cryocatheter. The Arctic Front® Cardiac CryoAblation Catheter System is commercially available for use in Europe and certain other countries outside the United States and is under investigational use in the United States.
The STOP AF study was sponsored by Medtronic CryoCath LP. The Principal Investigator was Dr. Douglas Packer of the Mayo Clinic in Rochester, Minnesota.