Continued Access Protocol (CAP-AF)
|ClinicalTrials.gov Identifier: NCT00889681|
Recruitment Status : Completed
First Posted : April 29, 2009
Results First Posted : April 25, 2014
Last Update Posted : April 25, 2014
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Device: Arctic Front Cardiac Cryoablation System|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CAP-AF: Continued Access Protocol for the Evaluation of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation|
|Study Start Date :||March 2009|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
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.
- Cryoablation Procedure Events (CPEs) [ Time Frame: 365 days ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|