Clinical trial NCT01456949: Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Official title: Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation (PAF)
Keywords: Atrial fibrillation (AF)
Paroxysmal atrial fibrillation (PAF)
Arrythmias
Cardiac Arrythmias
Cardiac ablation
Cryoablation
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2011-10-21
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months
timeFrame: Through 36 months
measure: Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years.
timeFrame: Annually, through 3 years
measure: Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years
timeFrame: Annually, at 1 and 2 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Phoenix
country: United States
facility: Banner Good Samaritan Medical Center
state: Arizona
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Denver
country: United States
facility: Colorado Heart and Vascular
state: Colorado
city: Daytona Beach
country: United States
facility: Daytona Heart Group
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: South Bend
country: United States
facility: Memorial Advanced Cardiovascular Institute
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Coon Rapids
country: United States
facility: Metropolitan Cardiology Consultants PA
state: Minnesota
city: Rochester
country: United States
facility: St. Mary's Hospital - Mayo Clinic
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Lincoln
country: United States
facility: Bryan LGH
state: Nebraska
city: Asheville
country: United States
facility: Asheville Cardiology Associate PA
state: North Carolina
city: Cincinnati
country: United States
facility: Bethesda North Hospital l TriHealth Hatton Institute
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Cardiovascular Associates
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Cardiology Associates
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Heart & Stroke
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Heart Clinic
state: South Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Research Institute
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Saint Luke's Episcopal Hospital - Texas Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials Inc
state: British Columbia
city: Montreal
country: Canada
facility: Hôpital du Sacre Coeur de Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
Study officials:
affiliation: Northwestern Memorial Hospital
name: Bradley P. Knight, MD, FACC, FHRS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.