NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

Completed · Phase 3

Conditions studied: Heart Diseases, Arrhythmia, Atrial Fibrillation

In brief

This trial compares the safety and effectiveness of catheter ablation for PAF with antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Key facts

Study ID

NCT00116428

Run by

Biosense Webster, Inc.

People needed

167

Starts

2004-10-01

Expected to finish

2011-03-01

Last updated by the study team

2017-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) 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 AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD.
• Signed Patient Informed Consent Form.
• Age 18 years or older.
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

You may not qualify if…

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous ablation for atrial fibrillation.
• Patients on amiodarone therapy at any time during the previous six (6) months.
• AF episodes that last longer than 30 days and are terminated via cardioversion.
• Any valvular cardiac surgical procedure.
• CABG procedure within the last 180 days (six months).
• Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
• Documented left atrial thrombus on imaging (e.g. TEE).
• History of a documented thromboembolic event within the past one (1) year.
• Diagnosed atrial myxoma.
• Presence of implanted ICD.
• Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive 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 (two months).
• LVEF < 40%.
• History of blood clotting or bleeding abnormalities.
• Contraindication to anticoagulation (i.e. heparin or warfarin).
• Contraindication to CT/MRA procedure.
• Life expectancy less than 360 days (12 months).
• Enrollment in an investigational study evaluating another device or drug.
• Uncontrolled heart failure or NYHA class III or IV heart failure.
• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The Heart Hospital Baylor Plano Baylor Research Institute — Plano, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Hospital Sao Paulo — São Paulo, Brazil
• Montreal Heart Institute — Montreal, Quebec, Canada
• Na Homolce Hospital — Prague, Motol, Czechia
• Hospital San Raffaele — Milan, Italy
• Marin General Hospital — Greenbrae, California, United States
• Florida Hospital — Orlando, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• St. Lukes Roosevelt Hospital — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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