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

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation (PAF)

• Registration Number: NCT01456949
• Lead Sponsor: Medtronic Cardiac Ablation Solutions

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.

Study Timeline

• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Study Start: 2012-06-26
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Results First Submitted: 2018-11-21
• Results First Submitted QC: 2018-12-19
• Results First Posted: 2019-01-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months	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)
Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months	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).

Secondary Outcome Measures

Name	Time	Method
Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years	Annually, 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)
Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years.	Annually, through 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.

Trial Locations

Locations (39)

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

Scroll for more (29 remaining)