NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study
Condition: Heart Diseases; Arrhythmia; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Heart Diseases
Intervention: Radiofrequency Ablation
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Ablation; Non-randomized

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.
    

Eligibility criteria:

        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.