Please select the eligibility criteria that correspond to the clinical trial below.
Title: NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation
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.


Options:
A: Inclusion Criteria:

* Subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (AF) after having failed \>or= 1 anti-arrhythmic drug.
B: 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
C: Inclusion Criteria:

1. Age 18-70 years
2. History of symptomatic paroxysmal AF lasting more than 6 months. Paroxysms of AF are intended as recurrent self-terminating episodes lasting less than 7 days and occurring more than 2 times every month.

Exclusion Criteria:

1. Pregnancy
2. NYHA functional class III or IV
3. Left atrial size \> 65 mm
4. Left ventricular (LV) ejection fraction \< 35%
5. Contraindication to anticoagulation with warfarin
6. History of myocardial infarction within six months of the procedure
7. Prior catheter or surgical ablation attempt for AF
8. Inability or unwillingness to provide written informed consent
9. Life expectancy less than 1 year
10. Significant comorbid conditions such as: cancer (not cured), end stage renal disease (creatinine clearance \< 20 mL/h), severe chronic obstructive lung disease, cirrhosis, etc)
11. Anticipated cardiac surgery for congenital, valvular, aortic or coronary heart disease.
12. Presence of left atrial thrombus.
13. Prior antiarrhythmic drug therapy with amiodarone, sotalol and flecainide at optimal doses (target 200 mg, 240 mg, 200 mg daily respectively
14. AF burden \< 2 episodes/month
15. WPW
16. Expected survival \< 1 year
17. Contraindications for antiarrhythmics therapy including flecainide, sotalol or amiodarone not listed above:

    * LV hypertrophy (LV mass index \> 125g/m2)
    * thyroid dysfunction (hyperthyroidism or uncontrolled hypothyroidism or thyroid cancer)
    * liver dysfunction (ALT or AST \>2x the reference values)
    * Interstitial lung disease with DLCO\<70% of predicted or severe asthma.
    * QT interval exceeding 400 msec
    * Symptomatic sinus node or atrioventricular node dysfunction unless a pacemaker had been implanted
    * Evidence of stress-induced myocardial ischemia
D: Inclusion Criteria:

1. Patients with one of the following AF categories and at least one ECG documentation of AF

   * High burden Paroxysmal defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode \> 6 hours (and no episode requiring cardioversion and no episode \> 7 days)
   * Persistent AF (1) defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode \> 6 hours, and at least one AF episode less than 7 days but requires cardioversion. No AF episodes are \> 7 days
   * Persistent AF (2) as defined by at least one episode of AF \> 7 days but not \> 1 year
   * Long term persistent AF defined as an AF episode, at least one year in length and no episodes \> 3 years
2. Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
3. HF with NYHA class II or III symptoms with either impaired LV function (LVEF ≤ 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF \> 45%) determined by by EF assessment within the previous 12 months
4. NT-pro BNP measures:

   A) Patient has been hospitalized for Heart Failure\* in the past 9 months, has been discharged AND:

   i- Is presently in Normal Sinus Rhythm and NT-pro BNP is ≥ 400 pg/mL

   ii- Is presently in Atrial Fibrillation and NT-pro BNP is ≥ 600 pg/mL

   OR

   B) Patient has had no hospitalization for Heart Failure in the past 9 months AND:

   i- Has had paroxysmal Atrial Fibrillation, is presently in Normal Sinus Rhythm and NT-proBNP is ≥ 600 pg/mL

   ii- Is presently in Atrial Fibrillation and NT-proBNP is ≥ 900 pg/mL

   \*Heart Failure Admission is defined as admission to hospital \> 24 hours and received treatment for Heart failure
5. Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
6. Age ≥18

Exclusion Criteria:

1. Have an LA dimension \> 55 mm as determined by an echocardiography within the previous year
2. Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
3. Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
4. Have congenital heart disease including previous ASD repair, persistent left superior vena cava
5. Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
6. Have a medical condition likely to limit survival to \< 1 year
7. Have New York Heart Association (NYHA) class IV heart failure symptoms
8. Have contraindication to systematic anticoagulation
9. Have renal failure requiring dialysis
10. AF due to reversible cause e.g. hyperthyroid state
11. Are pregnant
12. Are included in other clinical trials that will affect the objectives of this study
13. Have a history of non-compliance to medical therapy
14. Are unable or unwilling to provide informed consent

Answer: B