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NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (AFTX)

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. Identifier: NCT00721149
Recruitment Status : Terminated (Enrollment stopped after CDRH Advisory Panel (Nov 20, 2008) recommended NAVISTAR® THERMOCOOL® catheter approval.)
First Posted : July 23, 2008
Results First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Information provided by (Responsible Party):
Biosense Webster, Inc.

Tracking Information
First Submitted Date  ICMJE July 21, 2008
First Posted Date  ICMJE July 23, 2008
Results First Submitted Date  ICMJE February 8, 2013
Results First Posted Date  ICMJE January 22, 2014
Last Update Posted Date January 22, 2014
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361. [ Time Frame: From study day 91 through day 361 ]
    A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).
  • The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2008)
  • The primary efficacy endpoint is freedom from documented symptomatic PAF episodes from days 91-361. [ Time Frame: 1 year ]
  • The primary safety endpoint is the incidence of early onset (within 7 days of ablation procedure) catheter-related adverse events. [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT00721149 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • Percentage of Subjects Who Achieved Acute Success [ Time Frame: Day 91 - 361 ]
    Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.
  • 24-hour Holter Data [ Time Frame: 1 year ]
  • TTM Data [ Time Frame: 1 year ]
  • Percentage of Subjects Who Responded to Quality of Life Assessment [ Time Frame: 1 year ]
    SF 36 Symptom Frequency and Severity Checklist
Original Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2008)
  • Secondary Endpoints AF Status will be evaluated for each subject by assessing: Quality of Life (QOL) scores [ Time Frame: 1 year ]
  • 24-hour Holter Data [ Time Frame: 1 year ]
  • TTM Data [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
Official Title  ICMJE NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
Brief Summary This trial evaluates the safety and effectiveness of catheter ablation for PAF. 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 sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Heart Diseases
  • Arrhythmia
  • Atrial Fibrillation
Intervention  ICMJE Device: Radiofrequency Ablation
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.
Study Arms  ICMJE Experimental: NaviStar ThermoCool
Intervention: Device: Radiofrequency Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 3, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2008)
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
Administrative Information
NCT Number  ICMJE NCT00721149
Other Study ID Numbers  ICMJE BWI03130TXA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biosense Webster, Inc.
Study Sponsor  ICMJE Biosense Webster, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Wilber, MD Loyola University Medical Center Chicago
PRS Account Biosense Webster, Inc.
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP