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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Tbilisi Heart & Vascular Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GP Ablation; Single arm study with GP ablations performed during open-chest surgery	Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.; Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Patients in Sinus Rhythm at 12 Months.	Patients will be monitored with 24 hour Holter at 12 months	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extension of AERP	The acute increase in atrial effective refractory period (AERP) i.e. by comparing AERP values from immediately before and immediately after ablation.	Day 0

Collaborators and Investigators

• Sponsor: Atrian Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CIP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No