AcQForce Pulsed Field Ablation-CE

Study Overview
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Brief Summary
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The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)

Detailed Description
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This clinical study is designed to evaluate the safety and performance of the PFA System in the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory submissions.

Official Title
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The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)

Conditions
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Atrial Arrhythmia, Atrial Fibrillation

Intervention / Treatment
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* Device: Acutus Medical Pulsed Field Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female between the ages of 18 to 80 years at time of consent Clinically indicated and scheduled for a de novo catheter ablation of AF Willing and able to provide written informed consent to participate in the study and agree to comply with all follow-up visits and evaluations for the duration of the study. Exclusion Criteria: In the opinion of the investigator, any contraindication to the planned atrial ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis. Continuous episodes of AF duration lasting longer than 12-months Atrial arrhythmias secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause. Previous history of left atrial ablation (including surgical treatment) for AF/AT/AFL. Structural heart disease or cardiac history as described below: Left ventricular ejection fraction (LVEF) < 35% Left atrial size > 60 mm Evidence of heart failure (NYHA Class III or IV) Unstable angina or ongoing myocardial ischemia Recent myocardial infarction Severe uncontrolled systemic hypertension Moderate or severe valvular heart disease (stenosis or regurgitation). Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder. l. Presence of a left atrial appendage occlusion device. j. Previous PV stenting or evidence of PV stenosis. Body Mass Index (BMI) > 42 kg/m2 History of blood clotting or bleeding disease. ANY prior history of documented cerebral infarct (stroke), or systemic embolism (excluding post-operative deep vein thrombosis (DVT)). History of obstructive sleep apnea not currently being treated. Pregnant or lactating (current or anticipated during study follow-up). Any other condition that, in the judgment of the Investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Interventional Model Description: The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo ablation for atrial fibrillation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-randomized<br>All subjects will be ablated using the Acutus Medical Pulsed Field Ablation System (PFA System) in the management of their atrial fibrillation. | Device: Acutus Medical Pulsed Field Ablation System<br>* All subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who are free from device/procedure related Major Adverse Events | The Primary Endpoint for Safety is an analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the ablation procedure through 6-months. | 6 months | 
| Acute documentation of pulmonary vein isolation (PVI) for each treated pulmonary vein (PV) | The Primary Endpoint for efficacy is the number of subjects where ablation of each accessible pulmonary vein (PV) resulted in confirmation of electrical isolation of the pulmonary vein (PVI) 20 minutes following the last index PFA/RF application with the investigational device | 20 minutes post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of all identified SAEs, SADEs, and UADEs | The Secondary Endpoint for Safety is a recording and analysis of all identified serious adverse events (SAEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs). | 12 months | 
| Subjects with freedom from an atrial arrhythmia | The Secondary Endpoint for Performance is documentation of subjects with freedom from an atrial arrhythmia at 12-months post index procedure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, ablation, pulsed field ablation (PFA)