The purpose of this study is to compare two types of treatment for paroxysmal atrial fibrillation that are designed to maintain a normal heart rhythm. The treatments being compared are (1) medications called antiarrhythmic drugs to maintain a normal heart rhythm by preventing atrial fibrillation (AF); and (2) catheter ablation using the NAVISTAR® THERMOCOOL® catheter to prevent atrial fibrillation.

Condition	Intervention	Phase
Heart Diseases Arrhythmia Atrial Fibrillation	Device: NAVISTAR® THERMOCOOL® catheter	Phase III

Further Study Details: 

Expected Total Enrollment:  230

This study is a prospective, randomized, unblinded, multicenter pivotal clinical investigation that will enroll up to 230 participants using a 2:1 randomized scheme for the test (ablation procedure) and control (medical therapy) groups, respectively. Participants with symptomatic paroxysmal atrial fibrillation will be considered for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with symptomatic paroxysmal atrial fibrillation who have had 3 atrial fibrillation episodes in the 3 months prior to randomization, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
• Failure of at least one antiarrhythmic drug (AAD) for paroxysmal atrial fibrillation as evidenced by recurrent symptomatic atrial fibrillation, or intolerable side effects due to AAD.
• Signed patient informed consent form.
• Ages 18 years or older.
• Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

• Atrial fibrillation of non-cardiac origin.
• Previous ablation for atrial fibrillation.
• Patients on amiodarone therapy at any time during the previous six months.
• AF episodes that last longer than 30 days and are terminated via cardioversion.
• History of any valvular cardiac surgical procedure.
• Coronary artery bypass graft (CABG) procedure within the last 6 months.
• Awaiting cardiac transplantation or other cardiac surgery within the next year
• Documented left atrial thrombus on imaging (e.g. transesophageal echocardiogram).
• History of a documented thromboembolic event within the past year.
• Diagnosed atrial myxoma (soft tumor).
• Presence of implanted implantable cardioverter defibrillator (ICD).
• Significant pulmonary disease, or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
• Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
• Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
• Acute illness or active systemic infection or sepsis.
• Unstable angina.
• Myocardial infarction within the previous 60 days

Please refer to this study by ClinicalTrials.gov identifier  NCT00116428

Illinois
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
Massachusetts
      Brigham and Women’s Hospital, Cardiology Division, Boston,  Massachusetts,  02115,  United States; Recruiting
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States; Recruiting
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Recruiting
Oklahoma
      University of Oklahoma, Cardiac Arrhythmia Research Institute, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

Study ID Numbers:  BWI03130
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 29, 2005
ClinicalTrials.gov Identifier:  NCT00116428
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05