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Continued Access Protocol (CAP-AF)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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 Atrial Fibrillation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Good Samaritan
  • Cedars Sinai Medical Center
  • Stanford Hospital & Clinical
  • Bay Heart Group
  • Piedmont Hospital
  • Massachusetts General Hospital
  • Mayo Clinic
  • Baylor Heart & Vascular Hospital
  • Inova Research Center
  • Virginia Commonwealth University Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ablation

Arm Description

All study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.

Outcomes

Primary Outcome Measures

Cryoablation Procedure Events (CPEs)
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)
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)
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2009
Last Updated
September 17, 2018
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00889681
Brief Title
Continued Access Protocol
Acronym
CAP-AF
Official Title
CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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). 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ablation
Arm Type
Experimental
Arm Description
All study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.
Intervention Type
Device
Intervention Name(s)
Arctic Front Cardiac Cryoablation System
Other Intervention Name(s)
Arctic Front® Catheter Ref# 2AF232 & 2AF282, Manual Retraction Kit Ref# 20MRK, Freezor MAX Catheter Ref # 239F3 & 239F5, Console Ref # 106A2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cryoablation Procedure Events (CPEs)
Description
Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Time Frame
365 days
Title
Acute Procedural Success (APS)
Description
Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
Time Frame
At the conclusion of the cryoablation procedure
Title
Freedom From Major Atrial Fibrillation Events (MAFE)
Description
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.
Time Frame
365 days
Title
Long-term Clinical Success
Description
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.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must fulfill ALL of the following criteria: 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 18 and 75 years of age 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: 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 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. 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 Unwilling or unable to comply fully with study procedures and follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Packer, MD
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Good Samaritan
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford Hospital & Clinical
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5288
Country
United States
Facility Name
Bay Heart Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Baylor Heart & Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Inova Research Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

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Continued Access Protocol

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