Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF (Neural-AF)

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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Pulsed Electric Field Ablation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia
    • Na Homolce Hospital
• Georgia
  • Tbilisi, Georgia
    • Tbilisi Heart & Vascular Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 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.
• 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 (New York Heart Association) 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 (C-Reactive Protein) 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: Pulsed Electric Field Energy Ablation; Ablation of ganglionated plexi (GP) structures on the epicardial surface of the heart delivered as a concomitant procedure during open heart surgery.	Procedure: Pulsed Electric Field Ablation; Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Device-related Primary Safety Adverse Events	Primary Safety Adverse Events include: Atrial perforation or excessive bleeding (excessive bleeding is defined as bleeding which requires any blood transfusion).; Pericarditis; Pericardial effusion; Cardiac tamponade (if either surgical or percutaneous drainage is required).; Constrictive pericarditis, requiring re-operation.; Newly developed sinus node dysfunction.; Newly developed first, second or third degree atrioventricular (AV) block; Vasovagal reactions during hospital stay; Ventricular fibrillation	30 days
Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart.	Confirmation of catheter access and delivery of pulsed electric field energy to each of the targeted ablation sites on the epicardial surface of the heart.	Intraprocedural - during the ablation procedure. Within 1 hour of sternotomy.

Collaborators and Investigators

• Sponsor: Atrian Medical Ltd.
• Investigators: Study Chair: Barry O'Brien, PhD, AtriAN Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

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-001

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