Continued Access Protocol (CAP-AF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Atrial Fibrillation Solutions
ClinicalTrials.gov Identifier:
NCT00889681
First received: April 24, 2009
Last updated: March 26, 2014
Last verified: March 2014

April 24, 2009
March 26, 2014
March 2009
October 2013   (final data collection date for primary outcome measure)
  • Cryoablation Procedure Events (CPEs) [ Time Frame: 365 days ] [ Designated as safety issue: No ]
    Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
  • Acute Procedural Success (APS) [ Time Frame: At the conclusion of the cryoablation procedure ] [ Designated as safety issue: No ]
    Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
  • Freedom From Major Atrial Fibrillation Events (MAFE) [ Time Frame: 365 days ] [ Designated as safety issue: No ]
    Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.
  • Long-term Clinical Success [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.
Safety:The primary safety outcome measures are: Cryoablation procedure Events (CPEs) major atrial fibrillation events (MAFEs) [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00889681 on ClinicalTrials.gov Archive Site
Not Provided
Effectiveness: the primary effectiveness outcome measures are: acute procedural success (APS) chronic treatment failure (CTF) [ Time Frame: 365 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Continued Access Protocol
CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation

This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.

  1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures—Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
  2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).
  3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Device: Arctic Front Cardiac Cryoablation System
The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.
Other Names:
  • Arctic Front® Catheter Ref# 2AF232 & 2AF282
  • Manual Retraction Kit Ref# 20MRK
  • Freezor MAX Catheter Ref # 239F3 & 239F5
  • Console Ref # 106A2
Experimental: Ablation
All study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.
Intervention: Device: Arctic Front Cardiac Cryoablation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Subjects must fulfill ALL of the following criteria:

  1. Documented PAF:

    • diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
    • 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
  2. 18 and 75 years of age
  3. Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

  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. Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:

    • negative β-HCG test within 7 days prior to Start Date
    • history of surgical sterilization
    • postmenopausal and free of menses for at least 12 months.
  28. Life expectancy less than one (1) year
  29. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study
  30. Unwilling or unable to comply fully with study procedures and follow-up
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889681
CAP PS-024
Yes
Medtronic Atrial Fibrillation Solutions
Medtronic Atrial Fibrillation Solutions
Medtronic
Principal Investigator: Douglas Packer, MD Mayo Clinic, Rochester MN
Medtronic Atrial Fibrillation Solutions
March 2014

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