Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS) (STOP AF PAS)

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation (PAF)
• Intervention / Treatment: Device: Medtronic 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.

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Alberta
    • Edmonton, Alberta, Canada
      • Royal Alexandra Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Victoria, British Columbia, Canada
      • Victoria Cardiac Arrhythmia Trials Inc
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University Health Centre
    • Montreal, Quebec, Canada
      • Montreal Heart Institute
    • Montreal, Quebec, Canada
      • Hopital Du Sacre Coeur de Montreal
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Heart Institute
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Medical Center
  • California
    • San Jose, California, United States, 95124
      • Good Samaritan Hospital
  • Colorado
    • Denver, Colorado, United States, 80204
      • Colorado Heart and Vascular
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Daytona Heart Group
    • Fort Lauderdale, Florida, United States, 33316
      • Broward General Medical Center
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Marietta, Georgia, United States, 30060
      • Wellstar Kennestone Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Memorial Advanced Cardiovascular Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metropolitan Cardiology Consultants PA
    • Rochester, Minnesota, United States, 55902
      • St. Mary's Hospital - Mayo Clinic
    • Saint Paul, Minnesota, United States, 55102
      • HealthEast St. Joseph's Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan LGH
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associate PA
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital l TriHealth Hatton Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Cardiovascular Associates
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Cardiology Associates
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster Heart & Stroke
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Columbia Heart Clinic
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Research Institute
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Saint Luke's Episcopal Hospital - Texas Medical Center
    • Plano, Texas, United States, 75093
      • Baylor Research Institute
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
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:

1. Any previous left atrial (LA) ablation (except permissible retreatment subjects)
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; Cryoablation	Device: 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 Names: Medtronic CryoCath CryoConsole; Arctic Front® Cardiac CryoAblation Catheter; Arctic Front Advance™ Cardiac CryoAblation Catheter; Freezor® MAX Cardiac CryoAblation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Annually, at 1 and 2 years

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Ablation Solutions
• Investigators: Principal Investigator: Bradley P. Knight, MD, FACC, FHRS, Northwestern Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2012
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimated): October 21, 2011

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cryoablation; Cardiac ablation; Atrial fibrillation (AF); Paroxysmal atrial fibrillation (PAF); Arrythmias; Cardiac Arrythmias
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: STOP AF PAS