STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry Clinical Investigation Plan
Primary Efficacy Objective
- Estimate the 36-month freedom from AF /AFL /AT recurrence using the Arctic Front™ Cardiac Cryoablation Catheter System.
Primary Safety Objective
- Estimate primary safety AE rates for cryoablation using the Arctic Front™ Cardiac Cryoablation Catheter System through 12-months.
Primary Investigator: Daniel Beyerbach