NAVISTAR® THERMOCOOL® Catheter for the Treatment of Atrial Fibrillation- TX
Recruitment status was Active, not recruiting
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. It is currently FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory Ventricular Tachycardia for MI patients. The catheter is approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Device: Radiofrequency Ablation
Biosense Webster, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study|
- The primary efficacy endpoint is freedom from documented symptomatic PAF episodes from days 91-361. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- The primary safety endpoint is the incidence of early onset (within 7 days of ablation procedure) catheter-related adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Secondary Endpoints AF Status will be evaluated for each subject by assessing: Quality of Life (QOL) scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 24-hour Holter data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- TTM data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
This is a prospective, non-randomized, multi-center trial that will enroll a maximum of 100 participants at up to 25 hospitals in North America.
We're trying to improve treatment for atrial fibrillation - you can help!
Do you have episodes of chest pain, palpitations or fainting? This may be due to a condition called "Paroxysmal Atrial Fibrillation". If drug therapy has not been successful to treat this condition or you have intolerable side effects due to medications you are currently taking to treat this condition, you may be eligible for this trial.
What is being studied?
This clinical trial is evaluating the safety and effectiveness of a non-drug treatment (medical device) called catheter ablation. This study is evaluating whether a particular investigational ablation catheter can be used safely and effectively to treat paroxysmal atrial fibrillation.
What does the treatment consist of?
In this procedure, thin flexible tubes (catheters) are inserted into a vein in the groin and threaded into the heart. An attachment at the tip of the catheter delivers electrical energy to the heart tissue. This results in a small, localized burn which modifies the areas of heart muscle.
Is this treatment dangerous?
All interventional treatments have risks. However, this procedure is widely used for other types of heart rhythm disorders in the U.S. and worldwide with low complication rates. The treatment of paroxysmal atrial fibrillation is a new indication for this particular catheter.
Why would I want to take part in this trial?
Currently in the U.S., atrial fibrillation is primarily treated with drug therapy. But about half of patients treated with antiarrhythmic drugs fail to achieve relief from atrial fibrillation or find the side effects of the drugs intolerable. The purpose of the study is to demonstrate whether catheter ablation is safe and effective for treating atrial fibrillation. You would therefore be helping to advance knowledge about the treatment of patients like yourself who have atrial fibrillation and who are either not getting relief from medications or are bothered by the drug's side effects.
|United States, Alabama|
|University of Alabama, Birmingham Medical Center|
|Birmingham, Alabama, United States, 35294|
|United States, Arizona|
|Arizona Arrhythmia Consultants|
|Scottsdale, Arizona, United States, 85251|
|United States, California|
|Marin General Hospital|
|Greenbrae, California, United States, 94904|
|United States, Florida|
|Florida Hospital Orlando|
|Orlando, Florida, United States, 32803|
|United States, Illinois|
|Loyola University Medical Center Chicago|
|Maywood, Illinois, United States, 60153|
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|St. Luke's Roosevelt Hospital|
|New York, New York, United States, 10025|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44106|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43212|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|The Pennsylvania State University and Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Texas Cardiac Associates|
|Rowlett, Texas, United States, 75088|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1CB|
|Principal Investigator:||David Wilber, MD||Loyola University Medical Center Chicago|