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

Paroxysmal Atrial Fibrillation (PAF) Clinical Trial

— STOP AF PAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456949
• Other study ID #: STOP AF PAS
• Status: Completed
• Phase: N/A
• Start date: June 26, 2012
• Est. completion date: November 30, 2017

Study information

• Verified date: December 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation (PAF)

Intervention

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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
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	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Cardiac Arrhythmia Trials Inc	Victoria	British Columbia
United States	Alaska Heart Institute	Anchorage	Alaska
United States	Asheville Cardiology Associate PA	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Capital Cardiovascular Associates	Camp Hill	Pennsylvania
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Bethesda North Hospital l TriHealth Hatton Institute	Cincinnati	Ohio
United States	Columbia Heart Clinic	Columbia	South Carolina
United States	Metropolitan Cardiology Consultants PA	Coon Rapids	Minnesota
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Daytona Heart Group	Daytona Beach	Florida
United States	Colorado Heart and Vascular	Denver	Colorado
United States	Doylestown Cardiology Associates	Doylestown	Pennsylvania
United States	Inova Fairfax Hospital	Fairfax	Virginia
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	University of Florida	Gainesville	Florida
United States	Stern Cardiovascular	Germantown	Tennessee
United States	Saint Luke's Episcopal Hospital - Texas Medical Center	Houston	Texas
United States	Lancaster Heart & Stroke	Lancaster	Pennsylvania
United States	Bryan LGH	Lincoln	Nebraska
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Saint Thomas Research Institute	Nashville	Tennessee
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Baylor Research Institute	Plano	Texas
United States	St. Mary's Hospital - Mayo Clinic	Rochester	Minnesota
United States	HealthEast St. Joseph's Hospital	Saint Paul	Minnesota
United States	Good Samaritan Hospital	San Jose	California
United States	Memorial Advanced Cardiovascular Institute	South Bend	Indiana
United States	Oklahoma Heart Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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