Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— Neural-AF-2  

Official title:

Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05426759
• Other study ID #: CIP-002
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 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 study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• 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 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
Georgia	Tbilisi Heart & Vascular Clinic	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Atrian Medical Ltd.

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients in sinus rhythm at 12 months.	Patients will be monitored with 24 hour Holter at 12 months	12 month
Secondary	Extension of AERP	Assessment of atrial effective refractory period (AERP) immediately after sternotomy and immediately after ablation, before the index cardiothoracic surgery commences.	Day 0, peri-procedural.