FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology

Study Overview
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Brief Summary
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This study is to evaluate the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap Software).

Detailed Description
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The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap Software) to identify atrial fibrillation sources and guide ablation therapy in patients with persistent atrial fibrillation.

Official Title
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A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation, Persistent

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 atrial 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, persistent or longstanding persistent atrial fibrillation < 36 months. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months. Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of AF (not applicable to De Novo subjects) Exclusion Criteria: LA diameter > 5.5 cm. Left ventricular ejection fraction (LVEF) < 35%. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation. Coagulopathy, bleeding diathesis or suspected procoagulant state. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure. Positive pregnancy test results for female patients of childbearing potential or breast feeding. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study. Mitral valve stenosis and/or severe mitral regurgitation. Valvular atrial fibrillation. Prosthetic valves. NYHA Class IV. History of MI within 3 months prior to procedure. Atrial septal defect (ASD) or left atrial appendage (LAA) closure device. Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis). Life expectancy < 12 months based on medical history or the medical judgement of the investigator. Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EGF-Guided Ablation Therapy<br>Subjects randomized to therapy will be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software). | 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. Subjects will undergo a cardioversion post ablation, as necessary.<br>* Other names: Ablamap Electrographic Flow Algorithm Technology;|
| No Intervention: Control - No Ablation Therapy<br>Subjects randomized to control will not be treated with cardiac ablation guided by the Ablacon Electrographic flow algorithm technology (Ablamap Software). The subjects will be cardioverted (as applicable) and the procedure will end. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint: the ability to successfully ablate AF sources identified by the EGF algorithm as measured by EGF maps of the atria pre and post ablation to determine if there is a diminished or absence of the source. | Acute procedure success defined as the ability to successfully ablate AF sources identified by the EGF algorithm | During the Procedure | 
| Primary Safety Endpoint: Freedom from serious adverse events | Freedom from serious adverse events related to the procedure through 7 days following the randomization procedure. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Endpoints: Consistency of sources | Consistency of sources identified by the Ablacon EGF algorithm between the randomization procedure and any applicable subsequent EGF-guided ablation procedures as assessed by remapping of the atria and the algorithm's ability to reproduce sources identified by a previous procedure | Post procedure through 12 months | 
| Secondary Efficacy Endpoints: 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). Documentation will be from Holter recordings or EKGs. | 3-12 months | 
| Secondary Efficacy Endpoints: Total number of EGF source ablations | Total number of EGF source ablations (count number of ablations during the procedure) | During the procedure | 
| Secondary Efficacy Endpoints: Total time of EGF source ablations | Total time of EGF source ablations (seconds) | During the procedure | 
| Secondary Efficacy Endpoints | Total fluoroscopy time (min/sec) | During the procedure | 
| Secondary Efficacy Endpoints | Total fluoroscopy dose (mgy) | During the procedure | 
| Secondary Efficacy Endpoints: Overall Procedure time | Overall Procedure time (hours/minutes) | During the procedure |