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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Paroxysmal Atrial Fibrillation (PAF)	Device: Medtronic Arctic Front® Cardiac CryoAblation System	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	402 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Study Start Date :	May 2012
Actual Primary Completion Date :	November 30, 2017
Actual Study Completion Date :	November 30, 2017

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Effectiveness [ Time Frame: 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)
2. Safety [ Time Frame: 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 :

1. Chronic Safety [ Time Frame: 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.
2. Chronic Effectiveness [ Time Frame: Annually, through 3 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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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  Show 39 Study Locations

Sponsors and Collaborators

Medtronic Atrial Fibrillation Solutions

Investigators

Principal Investigator:	Bradley P. Knight, MD, FACC, FHRS	Northwestern Memorial Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:	NCT01456949 History of Changes
Other Study ID Numbers:	STOP AF PAS
First Posted:	October 21, 2011
Last Update Posted:	December 21, 2017
Last Verified:	December 2017

Keywords provided by Medtronic Atrial Fibrillation Solutions:

Atrial fibrillation (AF); Paroxysmal atrial fibrillation (PAF); Arrythmias	Cardiac Arrythmias; Cardiac ablation; Cryoablation

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes