NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

Study Overview
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Brief Summary
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The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

Detailed Description
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This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.

Official Title
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NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: Atrial fibrillation ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for this registry must meet ALL of the following criteria: Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip. Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects. Age 18 years or older. Able and willing to comply with all pre-, post- and follow-up testing and requirements. Signed Patient Informed Consent Form. Exclusion Criteria: Candidates will be excluded from the registry if any of the following conditions apply: Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. AF episodes that last longer than 30 days and are terminated via cardioversion. CABG procedure within the last six (6) months. Awaiting cardiac transplantation or other cardiac surgery. Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA). History of a documented thromboembolic event within the past one (1) year. Diagnosed atrial myxoma. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry. 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. Uncontrolled heart failure. Myocardial infarction within the previous two (2) months. History of blood clotting or bleeding abnormalities. Contraindication to anticoagulation (i.e. heparin or warfarin). Life expectancy less than 12 months. Enrollment in an investigational study evaluating another device or drug. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: More-Experienced Physicians (MEP)<br>Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year. | Procedure: Atrial fibrillation ablation<br>* Radiofrequency ablation<br>|
| Experimental: Less-Experienced Physicians (LEP)<br>Physicians who perform less than 50 atrial fibrillation ablation procedures per year. | Procedure: Atrial fibrillation ablation<br>* Radiofrequency ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure. | The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236. | Seven days post ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Experienced Serious Adverse Events. | The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report). | First study day to 5 year post-ablation |