Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

Study Overview
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Brief Summary
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A prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery.

Detailed Description
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To assess the safety and feasibility of electroporation/Pulsed Electric Field (PEF) as a technology to achieve selective GP ablation. This treatment will be performed on 30 patients undergoing cardiothoracic surgery. Primary feasibility endpoint will be demonstration of ability to access and deliver Pulsed Electric Field energy to all of the targeted ablation sites.

Official Title
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Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Pulsed Electric Field Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is between 18 and 70 years. Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting. Legally competent and willing to sign the informed consent. Life expectancy of at least 2 years. Exclusion Criteria: • Previous cardiac surgery. Prior pericardial interventions. Prior pulmonary vein isolation (PVI). Previous or existing pericarditis. Persistent or long-standing persistent atrial fibrillation. Indication for surgical ablation or PVI for atrial fibrillation. Indication for concomitant surgical valve repair or replacement. Indication for concomitant left atrial appendage (LAA) ligation or excision. History of previous radiation therapy on the thorax. History of previous thoracotomy. Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA). The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs). Myocardial infarction within the previous 2 months. NYHA Class IV heart failure symptoms. Left ventricular ejection fraction (LVEF) < 40%, measured by transthoracic echocardiography (TTE). Left atrial (LA) diameter > 5.0 cm, measured by transthoracic echocardiography (TTE). The presence of left atrial thrombus when examined by transoesophageal echocardiography (TEE). The presence of AF attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes. Active infection or sepsis as evidenced by increased white blood cell count, elevated CRP or temperature > 38.5°C. Known or documented carotid stenosis > 80% Stroke or transient ischemic attack within the previous 6 months. Known or documented epilepsy. Pregnancy or child-bearing potential without adequate contraception. Circumstances that prevent follow-ups. Drug abuse. Patients cannot be enrolled in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed Electric Field Energy Ablation<br>ablation of ganglionated plexi structures on the epicardial surface of the heart delivered as a concomitant procedure during open heart surgery to eliminate atrial fibrillation | Procedure: Pulsed Electric Field Ablation<br>* catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety device related events | Rate of device related adverse events | 30 days | 
| Feasibility of delivering electric energy on the epicardial surface of the heart to eliminate AF | Confirmation of access and delivery of pulsed electric field energy to ablation sites | Intraprocedural |