Atrial Fibrillation Clinical Trial
Official title:
CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.
1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter
System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the
continuous survival of subjects free from one or more primary safety outcome
measures—Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events
(MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or
more Atrial Fibrillation Drugs (AFDs).
2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation
Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing
the continuous survival of subjects with success in the primary effectiveness outcome
measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial
fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation
Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter
System used in the PS-023 STOP AF Pivotal Trial.
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