Continued Access Protocol (CAP-AF)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation|
- 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.
|Study Start Date:||March 2009|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
All study subjects will be receive cryo ablation 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889681
|United States, Arizona|
|Banner Good Samaritan|
|Phoenix, Arizona, United States, 85006|
|United States, California|
|Cedars Sinai Medical Center|
|Los Angles, California, United States, 90048|
|Stanford Hospital & Clinical|
|Stanford, California, United States, 94305-5288|
|United States, Florida|
|Bay Heart Group|
|Tampa, Florida, United States, 33607|
|United States, Georgia|
|Atlanta, Georgia, United States, 30309|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Minnesota|
|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|
|Principal Investigator:||Douglas Packer, MD||Mayo Clinic, Rochester MN|