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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT01456949
First received: October 19, 2011
Last updated: September 12, 2016
Last verified: September 2016
History of Changes
  Purpose
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 Intervention Phase
Paroxysmal Atrial Fibrillation (PAF)
 Device: Medtronic Arctic Front® Cardiac CryoAblation System
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Atrial Fibrillation Solutions:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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)
Estimated Enrollment: 400
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm 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

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 60 months of follow-up post-cryoablation procedure.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456949

  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

Responsible Party: Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier: NCT01456949     History of Changes
Other Study ID Numbers: STOP AF PAS 
Study First Received: October 19, 2011
Last Updated: September 12, 2016
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 23, 2016