AF-FLOW Registry: This Study is to Evaluate Ablamap Software in Patients Undergoing Ablation for Atrial Fibrillation.

Study Overview
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Brief Summary
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This post-market global registry will evaluate the ability of the Ablamap® Software to identify atrial fibrillation sources and guide ablation therapy in patients with atrial fibrillation.

Detailed Description
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The AF-FLOW Registry is a prospective, multi-center global post-market registry that will obtain clinical data in order to characterize the performance of the Ablamap® Software for its intended use in a real-world setting. Specifically, we will evaluate the ability of the Ablamap® Software to identify AF sources and guide ablation therapy in patients with atrial fibrillation. This registry will enroll up to 100 subjects. Subjects that present with atrial fibrillation and meet inclusion/exclusion criteria will be eligible for enrollment.

Official Title
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A Post Market, Global Registry to Evaluate the Identification of Atrial Fibrillation Sources Using the Ablamap® Electrographic FLOW (EGF) Mapping System to Guide Ablation Therapy in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation, Persistent, Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Pathologic Processes

Intervention / Treatment
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* Device: Ablamap Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suitable candidate for intra-cardiac mapping and ablation of arrhythmias. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. Subjects with a history of documented symptomatic atrial fibrillation. Exclusion Criteria: Subjects who are not candidates for cardiac ablation procedures. Pregnant or nursing. Presence of anatomic or comorbid conditions, or other medical, social or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or comply with follow-up requirements.

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 |
| --- | --- |
| EGF-Guided Ablation Therapy<br>Subjects will be treated with cardiac ablation guided by the Ablamap Electrographic Flow (EGF) Mapping System. | Device: Ablamap Software<br>* Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation.<br>* Other names: Ablamap Electrographic Flow Algorithm Technology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute procedure success defined as the ability to successfully ablate AF sources identified by the Ablamap software | The ability to successfully ablate AF sources identified by the Electrographic FLOW maps of the atria pre and post ablation to determine if there is a diminished or absence of the source. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from documented episodes of AF recurrence | Freedom from documented episodes of atrial fibrillation recurrence following the blanking period (90 days post procedure through 12 months). | 3-12 months |