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

Study Overview
=================
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.

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

Conditions
-----------------
Heart Diseases, Arrhythmia, Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: NAVISTAR® THERMOCOOL® Catheter
* Drug: Antiarrhythmic drug


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAVISTAR® THERMOCOOL® Catheter<br> | Device: NAVISTAR® THERMOCOOL® Catheter<br>* 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.<br>|
| Active Comparator: Antiarrhythmic drug<br> | Drug: Antiarrhythmic drug<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) | 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. | 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. | 
| The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events | 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. | Within 7 Days of Ablation Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Who Achieved Acute Success. | 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. | 90 days post study procedure | 
| Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up. | At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation. | During the two years of post procedure | 
| Percentage of Subjects Responded to Each of the Four Health Status Categories. | At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation. | During the two years of post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Paroxysmal Atrial Fibrillation