The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.
Safety and effectiveness will be evaluated against pre-specified performance criteria as determined by the sponsor and FDA. The criteria set in this study have been previously used to demonstrate safety and effectiveness in cryoablation and radio-frequency ablation for the treatment of paroxysmal atrial fibrillation. The analyses of the primary effectiveness objective will take place once all the subjects with a study cryoablation procedure attempt have reached 36 months of follow-up post-cryoablation procedure. The analysis of the primary safety objective will take place once all the subjects with a study cryoablation procedure attempt have reached 12 months of follow-up post-cryoablation procedure. The analyses for the secondary objectives will take place once all subjects with a study cryoablation attempt have reached 36 months of follow-up post-cryoablation procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
402
Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months
Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs). Chronic treatment failure is defined as: * Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR * Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)
Time frame: Through 36 months
Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months
Demonstrate safety (through 12 months) of Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the rate of subjects experiencing Cryoablation Procedure Events (CPEs) with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
Time frame: 12 Months
Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years.
Freedom from Major Atrial Fibrillation Event (MAFE): A MAFE is a serious adverse event (SAE) which has not been categorized as a cryoablation procedure event.
Time frame: Annually, through 3 years
Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years
Freedom from chronic treatment failure, defined as: * Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR * Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)
Time frame: Annually, at 1 and 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alaska Heart Institute
Anchorage, Alaska, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Good Samaritan Hospital
San Jose, California, United States
Colorado Heart and Vascular
Denver, Colorado, United States
Daytona Heart Group
Daytona Beach, Florida, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
University of Florida
Gainesville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
...and 29 more locations