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Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation (Neural-AF-2)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
Pulsed Field Ablation of epicardial Ganglionated Plexi.
Sponsored by
Atrian Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tbilisi Heart & Vascular Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GP Ablation

Arm Description

Single arm study with GP ablations performed during open-chest surgery

Outcomes

Primary Outcome Measures

The number of patients in sinus rhythm at 12 months.
Patients will be monitored with 24 hour Holter at 12 months

Secondary Outcome Measures

Extension of AERP
Assessment of atrial effective refractory period (AERP) immediately after sternotomy and immediately after ablation, before the index cardiothoracic surgery commences.

Full Information

First Posted
June 14, 2022
Last Updated
July 19, 2023
Sponsor
Atrian Medical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05426759
Brief Title
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Acronym
Neural-AF-2
Official Title
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atrian Medical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GP Ablation
Arm Type
Experimental
Arm Description
Single arm study with GP ablations performed during open-chest surgery
Intervention Type
Device
Intervention Name(s)
Pulsed Field Ablation of epicardial Ganglionated Plexi.
Intervention Description
Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.
Primary Outcome Measure Information:
Title
The number of patients in sinus rhythm at 12 months.
Description
Patients will be monitored with 24 hour Holter at 12 months
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Extension of AERP
Description
Assessment of atrial effective refractory period (AERP) immediately after sternotomy and immediately after ablation, before the index cardiothoracic surgery commences.
Time Frame
Day 0, peri-procedural.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tbilisi Heart & Vascular Clinic
City
Tbilisi
Country
Georgia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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