Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

Study Overview
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Brief Summary
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The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

Official Title
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Irrigated Ablation System Evaluation for AF

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: SJM Irrigated Cardiac Ablation System
* Device: FDA approved Open Irrigated RF Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Signed Patient Informed Consent Form Able and willing to comply with all pre-, post-, and follow-up testing and requirements Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD Subjects with symptomatic paroxysmal atrial fibrillation (PAF)* PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days. Exclusion Criteria: Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Previous ablation for AF History of any valvular cardiac surgical procedure Coronary artery bypass grafting (CABG) procedure within the last six months Awaiting cardiac transplantation or other cardiac surgery within the next 12 months Left atrial thrombus History of a documented thromboembolic event within the past one (1) year Diagnosed atrial myxoma An implanted implantable cardioverter defibrillator (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 two months Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure transthoracic echocardiogram (TTE) History of blood clotting or bleeding abnormalities Contraindication to anticoagulation (i.e. heparin or warfarin) Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure Life expectancy less than 12 months Enrollment in an investigational study evaluating another device or drug Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure An 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 as determined by pre-procedure TTE

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: St. Jude Medical Cardiac Ablation System<br> | Device: SJM Irrigated Cardiac Ablation System<br>* Irrigated ablation catheter<br>|
| Active Comparator: FDA approved Open Irrigated Radio Frequency Ablation System<br> | Device: FDA approved Open Irrigated RF Ablation System<br>* Irrigated ablation catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of Entrance Block in the Pulmonary Veins |  | 20 minutes after initial isolation | 
| Incidence of Adverse Events Included in the Pre-specified Composite | Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications. | 7 days | 
| Incidence of Adverse Events Included in the Pre-specified Composite. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period |  | 12 months | 
| Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs | Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs) | 12 months |