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NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation (Afib IDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00116428
Recruitment Status : Completed
First Posted : June 30, 2005
Results First Posted : March 14, 2013
Last Update Posted : October 24, 2017
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Diseases Arrhythmia Atrial Fibrillation Device: NAVISTAR® THERMOCOOL® Catheter Drug: Antiarrhythmic drug Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
Actual Study Start Date : October 1, 2004
Actual Primary Completion Date : October 1, 2007
Actual Study Completion Date : March 1, 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NAVISTAR® THERMOCOOL® Catheter Device: NAVISTAR® THERMOCOOL® Catheter
The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.

Active Comparator: Antiarrhythmic drug Drug: Antiarrhythmic drug
Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.

Primary Outcome Measures :
  1. The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) [ Time Frame: The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure. ]
    Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.

  2. The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events [ Time Frame: Within 7 Days of Ablation Procedure ]
    Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis,diaphragmatic paralysis, atrio-esophageal fistula,transient ischemic attack,stroke,cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade,pericardial effusion,pneumothorax,atrial perforation,vascular access complications,pulmonary edema,hospitalization (initial and prolonged), and heart block.

Secondary Outcome Measures :
  1. The Percentage of Subjects Who Achieved Acute Success. [ Time Frame: 90 days post study procedure ]
    Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.

  2. Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up. [ Time Frame: During the two years of post procedure ]
    At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.

  3. Percentage of Subjects Responded to Each of the Four Health Status Categories. [ Time Frame: During the two years of post procedure ]
    At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

You may be eligible to participate in this study if you: Have failed to respond to drug treatment for your AFib, or find the side effects of your medication intolerable.

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • Presence of a condition that precludes vascular access.
  • Left atrial size ≥ 50 mm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116428

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Sponsors and Collaborators
Biosense Webster, Inc.
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Principal Investigator: David Wilber, MD Loyola University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00116428    
Other Study ID Numbers: BWI03130
First Posted: June 30, 2005    Key Record Dates
Results First Posted: March 14, 2013
Last Update Posted: October 24, 2017
Last Verified: September 2017
Keywords provided by Biosense Webster, Inc.:
Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents