Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (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: August 25, 2014
Last verified: August 2014
  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:


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)
Intervention Details:
    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
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

  Hide Study Locations
Locations
United States, Alaska
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
United States, Arizona
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
United States, California
Good Samaritan Hospital
San Jose, California, United States, 95124
United States, Colorado
Colorado Heart and Vascular
Denver, Colorado, United States, 80204
United States, Florida
Daytona Heart Group
Daytona Beach, Florida, United States, 32114
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Indiana
Memorial Advanced Cardiovascular Institute
South Bend, Indiana, United States, 46601
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Metropolitan Cardiology Consultants PA
Coon Rapids, Minnesota, United States, 55433
St. Mary's Hospital - Mayo Clinic
Rochester, Minnesota, United States, 55902
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
United States, Nebraska
Bryan LGH
Lincoln, Nebraska, United States, 68506
United States, North Carolina
Asheville Cardiology Associate PA
Asheville, North Carolina, United States, 28803
United States, Ohio
Bethesda North Hospital l TriHealth Hatton Institute
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States, 17011
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Doylestown Cardiology Associates
Doylestown, Pennsylvania, United States, 18901
Lancaster Heart & Stroke
Lancaster, Pennsylvania, United States, 17602
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Columbia Heart Clinic
Columbia, South Carolina, United States, 29203
United States, Tennessee
Stern Cardiovascular
Germantown, Tennessee, United States, 38138
Saint Thomas Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Saint Luke's Episcopal Hospital - Texas Medical Center
Houston, Texas, United States, 77030
Baylor Research Institute
Plano, Texas, United States, 75093
United States, Virginia
Inova Fairfax Hospital
Fairfax, Virginia, United States, 22031
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Victoria Cardiac Arrhythmia Trials Inc
Victoria, British Columbia, Canada
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada
Hôpital du Sacre Coeur de Montreal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec, Canada
Sponsors and Collaborators
Medtronic Atrial Fibrillation Solutions
Investigators
Principal Investigator: Bradley P. Knight, MD, FACC, FHRS Northwestern Memorial Hospital
  More Information

No publications provided

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: August 25, 2014
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 October 02, 2014