Continued Access Protocol - Full Text View

Sponsors and Collaborators:	CryoCath Technologies Inc. Medtronic
Information provided by:	CryoCath Technologies Inc.
ClinicalTrials.gov Identifier:	NCT00889681

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Device: Arctic Front Cardiac Cryoablation System

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation

Further study details as provided by CryoCath Technologies Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Effectiveness: the primary effectiveness outcome measures are: acute procedural success (APS) chronic treatment failure (CTF) [ Time Frame: 365 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	March 2009
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ablation: Experimental This study is a single arm, non-randomized controlled study of up to 80 patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF ("Atrial Fibrillation Drugs " or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
³ 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889681

Locations

United States, California
Stanford Hospital & Clinical
Stanford, California, United States, 94305-5288
United States, Florida
Bay Heart Group
Tampa, Florida, United States, 33607
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Texas
Baylor Heart & Vascular Hospital
Dallas, Texas, United States, 75226
United States, Virginia
Inova Research Center
Falls Church, Virginia, United States, 22042
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23219

Sponsors and Collaborators

CryoCath Technologies Inc.

Medtronic

Investigators

Principal Investigator:

Douglas Packer, MD

Mayo Clinic, Rochester MN

More Information

No publications provided

Responsible Party:	Mayo Clinic, Rochester MN ( Dr Douglas Packer )
Study ID Numbers:	CAP PS-024
Study First Received:	April 24, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00889681 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009