Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation (Neural-AF-2)

Atrian Medical

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.

Study type: Interventional

Funder types: Industry

Identifiers

NCT05426759

CIP-002

Details and patient eligibility

About

A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.

Full description

This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year follow-ups.

Enrollment: 12 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age is between 18 and 70 years.
• Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting and/or aortic valve repair/replacement
• Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months.
• 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 endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy
• Previous or existing pericarditis
• Use of amiodarone within the previous 12 months.
• Long-standing persistent atrial fibrillation
• Indication for mitral or tricuspid valve surgery
• 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
• New York Heart Association (NYHA) Class IV heart failure symptoms
• Left Ventricular Ejection Fraction (LVEF) < 40%, measured by transthoracic echocardiography (TTE)
• Left atrial diameter > 5.0 cm, measured by transthoracic echocardiography (TTE)
• The presence of left atrial thrombus when examined by transesophageal echocardiography (TEE)
• The presence of atrial fibrillation (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 C-reactive protein (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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

GP Ablation

Experimental group

Description:

Single arm study with GP ablations performed during open-chest surgery

Treatment:

Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.