Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Pulsed Electric Field Ablation

• Registration Number: NCT04775264
• Lead Sponsor: Atrian Medical Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Study Start: 2021-05-17
• Primary Completion: 2022-06-17
• Results First Submitted: 2022-08-03
• Study Completion: 2023-04-27
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Results First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulsed Electric Field Energy Ablation	Pulsed Electric Field Ablation	Ablation of ganglionated plexi (GP) structures on the epicardial surface of the heart delivered as a concomitant procedure during open heart surgery.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart.	Intraprocedural - during the ablation procedure. Within 1 hour of sternotomy.	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.
Number of Participants With Device-related Primary Safety Adverse Events	30 days	Primary Safety Adverse Events include: 1. Atrial perforation or excessive bleeding (excessive bleeding is defined as bleeding which requires any blood transfusion).; 2. Pericarditis; 3. Pericardial effusion; 4. Cardiac tamponade (if either surgical or percutaneous drainage is required).; 5. Constrictive pericarditis, requiring re-operation.; 6. Newly developed sinus node dysfunction.; 7. Newly developed first, second or third degree atrioventricular (AV) block; 8. Vasovagal reactions during hospital stay; 9. Ventricular fibrillation

Trial Locations

Locations (2)

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Tbilisi Heart & Vascular Clinic; 🇬🇪 Tbilisi, Georgia