Trial Information

Summary: STOP AF: A clinical study of the Arctic Front™ cryoablation balloon for the treatment of paroxysmal atrial fibrillation.

PS-023 is a randomized controlled clinical study. The purpose of this study is to determine whether this new catheter system (Arctic Front™ CryoAblation Catheters, FlexCath™ Steerable Sheath) is safe and effective for the treatment of paroxysmal atrial fibrillation, as well as to see if this treatment is better compared to a medication. This catheter system uses freezing energy, cryoablation, to ablate (destroy) abnormal tissue in or near the pulmonary veins. The experimental ablation catheters for treating atrial fibrillation that will be used in this study have been tested in animals and humans. A refrigerant (cooling material) is delivered within the catheter to cool the catheter tip. This freezes and destroys the cells at the entrance to the pulmonary veins. If the atrial fibrillation comes from somewhere else in the heart, another catheter, the Freezor® MAX, will be used to freeze that area. This experimental catheter also uses freezing to ablate abnormal tissue. Many atrial fibrillation patients also have another arrhythmia called atrial flutter. In order to treat or to prevent atrial flutter after the procedure, the Freezor® MAX catheter may be used to freeze the cells in the area of the heart where atrial flutter starts.

The subject will be placed in one of two groups by chance (called randomization). In one group patients will be given only antiarrhythmic medication to control their arrhythmia. This group will be called the control group. The other group will be given antiarrhythmic medication as well as being treated with cryoablation. This group will be called the experimental group. The subject will be randomly assigned (like the flip of a coin) to one of these two (2) groups. The subject will have two (2) chances out of three (3) of getting cryoablation and one (1) chance out of three (3) of getting medication only.

Inclusions

• Documented Paroxysmal Atrial Fibrillation (PAF):
  • PAF diagnosis
  • 2 episodes of PAF within the last 2 months
  • At least 1 episode of PAF must be documented
• Age 18-75
• Documented Effectiveness Failure of one (1) AF drug
• Willing to be randomized to either group and do full 12 month follow-up
• Able to follow standardized AF drug protocol

Exclusions

• Any cardioversion within 3 months or more than 2 within 2 years
• Amiodarone within 6 months
• LA size > 5.0cm
• Previous LA ablation/surgery, structural heart disease, heart failure class III or IV
• Hypertrophic cardiomyopathy, Mitral prosthesis
• Unstable angina, uncontrolled hyperthyroidism
• Stroke or TIA within 6 months, MI within 2 months, cardiac surgery within 3 months
• Thrombocytosis, thrombocytopenia
• Any condition contraindicating chronic anticoagulation
• EF < 40%
• Pregnancy
• Life expectancy < 1year

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.