Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF

NCT04775264 | Completed Results

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Device-related Primary Safety Adverse Events

  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

  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.

Study Arms (1)

Pulsed Electric Field Energy Ablation

EXPERIMENTAL

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

Interventions

Pulsed Electric Field Ablation PROCEDURE

Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery

Pulsed Electric Field Energy Ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Atrian Medical Ltd.: lead

Study Sites (2)

Na Homolce Hospital

Prague, Czechia

Location

Tbilisi Heart & Vascular Clinic

Tbilisi, Georgia

Location

Related Publications (1)

• Musikantow DR, Reddy VY, Skalsky I, Shaburishvili T, van Zyl M, O'Brien B, Coffey K, Reilly J, Neuzil P, Asirvatham S, de Groot JR. Targeted ablation of epicardial ganglionated plexi during cardiac surgery with pulsed field electroporation (NEURAL AF). J Interv Card Electrophysiol. 2025 Mar;68(2):467-474. doi: 10.1007/s10840-023-01615-8. Epub 2023 Aug 10.

  PMID: 37561246 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Barry O'Brien
• Organization: AtriAN Medical Ltd

barry.obrien@atrianmedical.com

+353872934292

Study Officials

• Barry O'Brien, PhD

  AtriAN Medical

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: May 17, 2021
• Primary Completion: June 17, 2022
• Study Completion: April 27, 2023
• Last Updated: February 9, 2024
• Results First Posted: February 9, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); GE (1)