Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
STOP AF PAS
1 other identifier
interventional
402
2 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 21, 2011
CompletedStudy Start
First participant enrolled
June 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedResults Posted
Study results publicly available
January 11, 2019
CompletedFebruary 13, 2025
February 1, 2025
5.4 years
October 19, 2011
November 21, 2018
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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).
12 Months
Secondary Outcomes (2)
Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years.
Annually, through 3 years
Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years
Annually, at 1 and 2 years
Study Arms (1)
Single Arm
OTHERCryoablation
Interventions
Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Eligibility Criteria
You may qualify if:
- Documented PAF:
- Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- 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.
You may not qualify if:
- 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%
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Alaska Heart Institute
Anchorage, Alaska, 99508, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
Colorado Heart and Vascular
Denver, Colorado, 80204, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
Broward General Medical Center
Fort Lauderdale, Florida, 33316, United States
University of Florida
Gainesville, Florida, 32610, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
WellStar Kennestone Hospital
Marietta, Georgia, 30060, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Memorial Advanced Cardiovascular Institute
South Bend, Indiana, 46601, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Metropolitan Cardiology Consultants PA
Coon Rapids, Minnesota, 55433, United States
St. Mary's Hospital - Mayo Clinic
Rochester, Minnesota, 55902, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102, United States
Bryan LGH
Lincoln, Nebraska, 68506, United States
Asheville Cardiology Associate PA
Asheville, North Carolina, 28803, United States
Bethesda North Hospital l TriHealth Hatton Institute
Cincinnati, Ohio, 45242, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104, United States
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, 17011, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Doylestown Cardiology Associates
Doylestown, Pennsylvania, 18901, United States
Lancaster Heart & Stroke
Lancaster, Pennsylvania, 17602, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Columbia Heart Clinic
Columbia, South Carolina, 29203, United States
Stern Cardiovascular
Germantown, Tennessee, 38138, United States
Saint Thomas Research Institute
Nashville, Tennessee, 37205, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Saint Luke's Episcopal Hospital - Texas Medical Center
Houston, Texas, 77030, United States
Baylor Research Institute
Plano, Texas, 75093, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22031, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, 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
Related Publications (1)
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.
PMID: 30898232DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kirsten Rasmussen
- Organization
- Medtronic
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley P. Knight, MD, FACC, FHRS
Northwestern Memorial Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 21, 2011
Study Start
June 26, 2012
Primary Completion
November 30, 2017
Study Completion
November 30, 2017
Last Updated
February 13, 2025
Results First Posted
January 11, 2019
Record last verified: 2025-02