Back to resultsSafety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF (Neural-AF)
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pulsed Electric Field Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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 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 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
- Na Homolce Hospital
- Tbilisi Heart & Vascular Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulsed Electric Field Energy Ablation
Arm Description
ablation of ganglionated plexi structures on the epicardial surface of the heart delivered as a concomitant procedure during open heart surgery to eliminate atrial fibrillation
Outcomes
Primary Outcome Measures
Primary Safety device related events
Rate of device related adverse events
Feasibility of delivering electric energy on the epicardial surface of the heart to eliminate AF
Confirmation of access and delivery of pulsed electric field energy to ablation sites
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04775264
Brief Title
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF
Acronym
Neural-AF
Official Title
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 17, 2023 (Anticipated)
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
5. Study Description
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.
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
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed Electric Field Energy Ablation
Arm Type
Experimental
Arm Description
ablation of ganglionated plexi structures on the epicardial surface of the heart delivered as a concomitant procedure during open heart surgery to eliminate atrial fibrillation
Intervention Type
Procedure
Intervention Name(s)
Pulsed Electric Field Ablation
Intervention Description
catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery
Primary Outcome Measure Information:
Title
Primary Safety device related events
Description
Rate of device related adverse events
Time Frame
30 days
Title
Feasibility of delivering electric energy on the epicardial surface of the heart to eliminate AF
Description
Confirmation of access and delivery of pulsed electric field energy to ablation sites
Time Frame
Intraprocedural
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.
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 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 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
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
Tbilisi Heart & Vascular Clinic
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF
We'll reach out to this number within 24 hrs