Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

Atrial Fibrillation Clinical Trial

— Neural-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775264
• Other study ID #: CIP-001
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: April 27, 2023

Study information

• Verified date: July 2023
• Source: Atrian Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 27, 2023
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulsed Electric Field Ablation
Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery

Locations

Country	Name	City	State
Czechia	Na Homolce Hospital	Prague
Georgia	Tbilisi Heart & Vascular Clinic	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Atrian Medical Ltd.

Countries where clinical trial is conducted

Czechia,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.