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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Medtronic Atrial Fibrillation Solutions
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01456949
First received: October 19, 2011
Last updated: May 19, 2014
Last verified: May 2014

October 19, 2011
May 19, 2014
May 2012
January 2018   (final data collection date for primary outcome measure)
  • Effectiveness [ Time Frame: Through 36 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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).
  • Demonstrate Arctic Front® Cardiac CryoAblation Catheter System effectiveness in treatment of paroxysmal atrial fibrillation [ Time Frame: Through 36 months ] [ Designated as safety issue: No ]

    Treatment effectiveness is 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 OR
    • Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)
  • Demonstrate Arctic Front® Cardiac CryoAblation Catheter System safety in treatment of paroxysmal atrial fibrillation [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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 a Cryoablation Procedure Events (CPEs) with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
Complete list of historical versions of study NCT01456949 on ClinicalTrials.gov Archive Site
  • Chronic Safety [ Time Frame: Annually, through 5 years ] [ Designated as safety issue: Yes ]
    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.
  • Chronic Effectiveness [ Time Frame: Annually, through 5 years ] [ Designated as safety issue: No ]

    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)
  • Subjects free from MAFE (Major Atrial Fibrillation Even) [ Time Frame: Annually, through 5 years ] [ Designated as safety issue: Yes ]
    Major Atrial Fibrillation Event (MAFE): A MAFE is a serious adverse event (SAE) — which has not been categorized as a CPE—as set out in the following
  • Subjects free from chronic treatment failure [ Time Frame: Annually, through 5 years ] [ Designated as safety issue: No ]

    Chronic treatment failure is defined as:

    • Documented atrial fibrillation lasting longer than 30 seconds OR
    • Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)
Not Provided
Not Provided
 
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

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.

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 60 months of follow-up post-cryoablation procedure.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation (PAF)
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
January 2020
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States,   Canada
 
NCT01456949
STOP AF PAS
Yes
Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Not Provided
Principal Investigator: Bradley P. Knight, MD, FACC, FHRS Northwestern Memorial Hospital
Medtronic Atrial Fibrillation Solutions
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP