NAVISTAR® THERMOCOOL® SF Catheter: Observational Study

Study Overview
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Brief Summary
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This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.

Detailed Description
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This study is to measure the real-world acute procedural outcomes (procedural efficiency, acute safety, and effectiveness at one year) associated with use of the NAVISTAR® THERMOCOOL® SF Catheter in a clinical setting in subjects with drug refractory, recurrent symptomatic paroxysmal atrial fibrillation.

Official Title
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NAVISTAR® THERMOCOOL® SF Catheter: Observational Study in a Younger and Older Drug Refractory, Recurrent, Symptomatic Paroxysmal AF Population

Conditions
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Atrial Fibrillation, Paroxysmal Arrhythmia

Intervention / Treatment
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* Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation Age 18 years or older Patients must be able and willing to provide written informed consent to participate in the study Exclusion Criteria: Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Previous ablation for atrial fibrillation Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion Uncontrolled heart failure, or NYHA Class III or IV heart failure Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram Contraindication to anticoagulation Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months Awaiting cardiac transplantation Heart disease in which corrective surgery is anticipated within 6 months Enrollment in investigational drug, biologic or device study Subjects unwilling to comply with protocol or follow-up requirements Patients who are pregnant

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Catheter Ablation<br>These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and have provided written informed consent to participate in the study, including consent to undergo catheter ablation with the study device. | Device: Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)<br>* Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Fluoroscopy Time | The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time. | Day 0 (procedure) | 
| Total Procedure Time |  | Day 0 (procedure) | 
| Acute Procedural Success | Confirmation of entrance and/or exit block across all targeted pulmonary veins. | Day 0 (procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Radiofrequency (RF) Applications | RF applications is defined as the number of times RF energy is delivered during the procedure. | Day 0 (procedure) | 
| Total Radiofrequency (RF) Time | Total RF time is defined as the total time that RF energy is delivered during the procedure. | Day 0 (procedure) | 
| Fluid Volume Delivered Via Ablation Catheter |  | Day 0 (procedure) | 
| Number of Patients With Repeat Ablations |  | 1 year | 
| Post-procedure AF Symptoms | Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit | 12 Month Visit | 
| Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit |  | 12 Month Visit | 
| Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation |  | 12 Month Visit | 
| Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation |  | 12 Month Visit | 
| Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score | Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding not at all limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms. | Screening to 12 Month Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic paroxysmal, Atrial fibrillation, Observational, Acute procedural outcomes, Ablation, Drug refractory, Arrhythmia Recurrent, Symptomatic