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

Primary Purpose

Paroxysmal Atrial Fibrillation (PAF)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Medtronic Arctic Front® Cardiac CryoAblation System
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation (PAF) focused on measuring Atrial fibrillation (AF), Paroxysmal atrial fibrillation (PAF), Arrythmias, Cardiac Arrythmias, Cardiac ablation, Cryoablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Heart Institute
  • Banner Good Samaritan Medical Center
  • Good Samaritan Hospital
  • Colorado Heart and Vascular
  • Daytona Heart Group
  • Broward General Medical Center
  • University of Florida
  • Emory University Hospital
  • WellStar Kennestone Hospital
  • Northwestern Memorial Hospital
  • Memorial Advanced Cardiovascular Institute
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Metropolitan Cardiology Consultants PA
  • St. Mary's Hospital - Mayo Clinic
  • HealthEast St. Joseph's Hospital
  • Bryan LGH
  • Asheville Cardiology Associate PA
  • Bethesda North Hospital l TriHealth Hatton Institute
  • Oklahoma Heart Institute
  • Capital Cardiovascular Associates
  • Geisinger Medical Center
  • Doylestown Cardiology Associates
  • Lancaster Heart & Stroke
  • University of Pittsburgh Medical Center
  • Columbia Heart Clinic
  • Stern Cardiovascular
  • Saint Thomas Research Institute
  • University of Texas Southwestern Medical Center
  • Saint Luke's Episcopal Hospital - Texas Medical Center
  • Baylor Research Institute
  • Inova Fairfax Hospital
  • Royal Alexandra Hospital
  • Vancouver General Hospital
  • Victoria Cardiac Arrhythmia Trials Inc
  • Hôpital du Sacre Coeur de Montreal
  • McGill University Health Centre
  • Montreal Heart Institute
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

Cryoablation

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

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.
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)

Full Information

First Posted
October 19, 2011
Last Updated
December 19, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT01456949
Brief Title
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Acronym
STOP AF PAS
Official Title
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 26, 2012 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation (PAF)
Keywords
Atrial fibrillation (AF), Paroxysmal atrial fibrillation (PAF), Arrythmias, Cardiac Arrythmias, Cardiac ablation, Cryoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
Cryoablation
Intervention Type
Device
Intervention Name(s)
Medtronic Arctic Front® Cardiac CryoAblation System
Other Intervention Name(s)
Medtronic CryoCath CryoConsole, Arctic Front® Cardiac CryoAblation Catheter, Arctic Front Advance™ Cardiac CryoAblation Catheter, Freezor® MAX Cardiac CryoAblation Catheter
Intervention Description
Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Primary Outcome Measure Information:
Title
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months
Description
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)
Time Frame
Through 36 months
Title
Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months
Description
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).
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years.
Description
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.
Time Frame
Annually, through 3 years
Title
Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years
Description
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)
Time Frame
Annually, at 1 and 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley P. Knight, MD, FACC, FHRS
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alaska Heart Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Colorado Heart and Vascular
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Daytona Heart Group
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
WellStar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Memorial Advanced Cardiovascular Institute
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Metropolitan Cardiology Consultants PA
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
St. Mary's Hospital - Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
HealthEast St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Bryan LGH
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Asheville Cardiology Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Bethesda North Hospital l TriHealth Hatton Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Capital Cardiovascular Associates
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Doylestown Cardiology Associates
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Lancaster Heart & Stroke
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Columbia Heart Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Stern Cardiovascular
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Saint Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Saint Luke's Episcopal Hospital - Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Research Institute
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Victoria Cardiac Arrhythmia Trials Inc
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Hôpital du Sacre Coeur de Montreal
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30898232
Citation
Knight BP, Novak PG, Sangrigoli R, Champagne J, Dubuc M, Adler SW, Svinarich JT, Essebag V, Hokanson R, Kueffer F, Jain SK, John RM, Mansour M; STOP AF PAS Investigators. Long-Term Outcomes After Ablation for Paroxysmal Atrial Fibrillation Using the Second-Generation Cryoballoon: Final Results From STOP AF Post-Approval Study. JACC Clin Electrophysiol. 2019 Mar;5(3):306-314. doi: 10.1016/j.jacep.2018.11.006. Epub 2018 Dec 26.
Results Reference
derived

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

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