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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Paroxysmal Atrial Fibrillation (PAF)

Intervention / Treatment
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* Device: Medtronic Arctic Front® Cardiac CryoAblation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Age 18 years or older Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control. Exclusion Criteria: 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% 2º (Type II) or 3º atrioventricular block Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function) Brugada syndrome Long QT syndrome Arrhythmogenic right ventricular dysplasia Sarcoidosis Hypertrophic cardiomyopathy Known cryoglobulinemia Uncontrolled hyperthyroidism Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date. Any woman known to be pregnant Life expectancy less than one (1) year 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 Unwilling or unable to comply fully with study procedures and followup

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Cryoablation | Device: Medtronic Arctic Front® Cardiac CryoAblation System<br>* Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.<br>* Other names: Freezor® MAX Cardiac CryoAblation Catheter;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation (AF), Paroxysmal atrial fibrillation (PAF), Arrythmias, Cardiac Arrythmias, Cardiac ablation, Cryoablation