CARTO® 3 System and Real Time Intracardiac Ultrasound

Study Overview
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Brief Summary
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This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).

Detailed Description
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This study is purposed to measure real world acute procedural outcomes (procedural efficiency and acute safety) associated with use of the CARTO® 3 System and real time intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent symptomatic paroxysmal AF.

Official Title
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CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study

Conditions
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Atrial Fibrillation, Paroxysmal AF

Intervention / Treatment
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* Device: Catheter Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug refractory, recurrent symptomatic paroxysmal AF Age 18 years or older Patients able and willing to provide written informed consent to participate in the study and comply with study requirements Exclusion Criteria: Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Previous ablation for atrial fibrillation AF episodes that last longer than 30 days Uncontrolled heart failure, or NYHA Class III or IV heart failure Documented intra-atrial thrombus or other abnormality on pre-ablation imaging Contraindication to anticoagulation Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months Awaiting cardiac transplantation Heart disease for which corrective surgery is anticipated within 6 months Enrollment in other investigational drug 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter Ablation<br>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements. | Device: Catheter Ablation<br>* NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)<br>* Other names: CARTO® 3 System and Real Time Intracardiac Ultrasound;|

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. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Procedure Time | The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total. | Day 0 | 
| Acute Procedural Success | Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins. | Day 0 | 
| Mean Number of Radiofrequency (RF) Applications | RF application is defined as the number of times RF energy is delivered during the procedure. | Day 0 | 
| Total Radiofrequency (RF) Time | Total RF time is defined as the total time RF is delivered during the procedure. | Day 0 | 

 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