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:||Allocation: Non-Randomized
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|
- 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 ]
- Effectiveness: the primary effectiveness outcome measures are: acute procedural success (APS) chronic treatment failure (CTF) [ Time Frame: 365 days ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
- 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.
|United States, Arizona|
|Banner Good Samaritan|
|Phoeniz, 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|