Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
NCT ID: NCT01456949
Last Updated: 2025-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
402 participants
INTERVENTIONAL
2012-06-26
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Cryoablation
Medtronic Arctic Front® Cardiac CryoAblation System
Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Interventions
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Medtronic Arctic Front® Cardiac CryoAblation System
Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
2. Age 18 years or older
3. Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.
Exclusion Criteria
2. Any previous LA surgery
3. Current intracardiac thrombus (can be treated after thrombus is resolved)
4. Presence of any pulmonary vein stents
5. Presence of any pre-existing pulmonary vein stenosis
6. Pre-existing hemidiaphragmatic paralysis
7. Anteroposterior LA diameter \> 5.5 cm by TTE
8. Presence of any cardiac valve prosthesis
9. Clinically significant mitral valve regurgitation or stenosis
10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
11. Unstable angina
12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
13. Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
14. NYHA class III or IV congestive heart failure
15. Left ventricular ejection fraction (LVEF) \< 40%
16. 2º (Type II) or 3º atrioventricular block
17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
18. Brugada syndrome
19. Long QT syndrome
20. Arrhythmogenic right ventricular dysplasia
21. Sarcoidosis
22. Hypertrophic cardiomyopathy
23. Known cryoglobulinemia
24. Uncontrolled hyperthyroidism
25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
26. Any woman known to be pregnant
27. Life expectancy less than one (1) year
28. 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
29. Unwilling or unable to comply fully with study procedures and followup
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Bradley P. Knight, MD, FACC, FHRS
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Locations
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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
Memorial Advanced Cardiovascular Institute
South Bend, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Metropolitan Cardiology Consultants PA
Coon Rapids, Minnesota, United States
St. Mary's Hospital - Mayo Clinic
Rochester, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
Bryan LGH
Lincoln, Nebraska, United States
Asheville Cardiology Associate PA
Asheville, North Carolina, United States
Bethesda North Hospital l TriHealth Hatton Institute
Cincinnati, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Doylestown Cardiology Associates
Doylestown, Pennsylvania, United States
Lancaster Heart & Stroke
Lancaster, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Columbia Heart Clinic
Columbia, South Carolina, United States
Stern Cardiovascular
Germantown, Tennessee, United States
Saint Thomas Research Institute
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Saint Luke's Episcopal Hospital - Texas Medical Center
Houston, Texas, United States
Baylor Research Institute
Plano, Texas, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Victoria Cardiac Arrhythmia Trials Inc
Victoria, 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
Québec, Quebec, Canada
Countries
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References
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Knight BP, Novak PG, Sangrigoli R, Champagne J, Dubuc M, Adler SW, Svinarich JT, Essebag V, Hokanson R, Kueffer F, Jain SK, John RM, Mansour M; STOP AF PAS Investigators. Long-Term Outcomes After Ablation for Paroxysmal Atrial Fibrillation Using the Second-Generation Cryoballoon: Final Results From STOP AF Post-Approval Study. JACC Clin Electrophysiol. 2019 Mar;5(3):306-314. doi: 10.1016/j.jacep.2018.11.006. Epub 2018 Dec 26.
Provided Documents
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Document Type: Study Protocol: Clinical Investigation Plan Version 4
Document Type: Study Protocol: Clinical Investigation Plan Version 5
Document Type: Study Protocol: Clinical Investigation Plan Version 6
Document Type: Statistical Analysis Plan
Other Identifiers
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STOP AF PAS
Identifier Type: -
Identifier Source: org_study_id
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