Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Interventions
- Device: Medtronic Arctic Front® Cardiac CryoAblation System
- Registration Number
- NCT01456949
- Lead Sponsor
- Medtronic Cardiac Ablation Solutions
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
-
Documented PAF:
- Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- 2 or more episodes of AF during the 3 months preceding the consent Date, AND
- At least 1 episode of AF documented with a tracing within 12 months preceding the consent date.
-
Age 18 years or older
-
Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.
- Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- Any previous LA surgery
- Current intracardiac thrombus (can be treated after thrombus is resolved)
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Anteroposterior LA diameter > 5.5 cm by TTE
- Presence of any cardiac valve prosthesis
- Clinically significant mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
- Unstable angina
- Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
- Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) < 40%
- 2º (Type II) or 3º atrioventricular block
- Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- Brugada syndrome
- Long QT syndrome
- Arrhythmogenic right ventricular dysplasia
- Sarcoidosis
- Hypertrophic cardiomyopathy
- Known cryoglobulinemia
- Uncontrolled hyperthyroidism
- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
- Any woman known to be pregnant
- Life expectancy less than one (1) year
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
- Unwilling or unable to comply fully with study procedures and followup
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Medtronic Arctic Front® Cardiac CryoAblation System Cryoablation
- Primary Outcome Measures
Name Time Method Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months 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)Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months 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).
- Secondary Outcome Measures
Name Time Method Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years Annually, 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)Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years. Annually, through 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.
Trial Locations
- Locations (39)
Inova Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
Victoria Cardiac Arrhythmia Trials Inc
🇨🇦Victoria, British Columbia, Canada
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Good Samaritan Hospital
🇺🇸San Jose, California, United States
Memorial Advanced Cardiovascular Institute
🇺🇸South Bend, Indiana, United States
Asheville Cardiology Associate PA
🇺🇸Asheville, North Carolina, United States
Daytona Heart Group
🇺🇸Daytona Beach, Florida, United States
Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Metropolitan Cardiology Consultants PA
🇺🇸Coon Rapids, Minnesota, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Stern Cardiovascular
🇺🇸Germantown, Tennessee, United States
HealthEast St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Columbia Heart Clinic
🇺🇸Columbia, South Carolina, United States
Doylestown Cardiology Associates
🇺🇸Doylestown, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor Research Institute
🇺🇸Plano, Texas, United States
Saint Luke's Episcopal Hospital - Texas Medical Center
🇺🇸Houston, Texas, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Hôpital du Sacre Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦Quebec, Canada
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
Colorado Heart and Vascular
🇺🇸Denver, Colorado, United States
St. Mary's Hospital - Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Saint Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Capital Cardiovascular Associates
🇺🇸Camp Hill, Pennsylvania, United States
Lancaster Heart & Stroke
🇺🇸Lancaster, Pennsylvania, United States
Bethesda North Hospital l TriHealth Hatton Institute
🇺🇸Cincinnati, Ohio, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Bryan LGH
🇺🇸Lincoln, Nebraska, United States
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States