Atrial FibrillationNeural-AFNCT04775264
Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for AF
A study testing Pulsed Electric Field Ablation in people with Atrial Fibrillation, run by Atrian Medical Ltd. at 2 sites in 2 countries.
Trial summary
A prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulsed Electric Field Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 17 May 2021to 27 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for Atrial Fibrillation
A prospective, single arm, multi-center exploratory study of safety and feasibility in the treatment of patients undergoing cardiothoracic surgery.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulsed Electric Field Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electric Field AblationProcedure or surgery
Catheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pulsed Electric Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device-related Primary Safety Adverse Events
Primary Safety Adverse Events include:
- Atrial perforation or excessive bleeding (excessive bleeding is defined as bleeding which requires any blood transfusion).
- Pericarditis
- Pericardial effusion
- Cardiac tamponade (if either surgical or percutaneous drainage is required).
- Constrictive pericarditis, requiring re-operation.
- Newly developed sinus node dysfunction.
- Newly developed first, second or third degree atrioventricular (AV) block
- Vasovagal reactions during hospital stay
- Ventricular fibrillation
Measured: 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.
Measured: Intraprocedural - during the ablation procedure. Within 1 hour of sternotomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start17 May 2021
- Primary completion17 Jun 2022
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrian Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry O'Brien, PhD, Study chair, AtriAN Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775264
- Sponsor's protocol ID
- CIP-001
- Acronym
- Neural-AF
- Status last verified
- Jul 2023
- First submitted
- 25 Feb 2021
- Last updated
- 9 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37561246
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Atrial Deganglionation as Adjunctive Therapy for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04775264
- Acronym / sponsor ID
- Neural-AF / CIP-001
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Atrian Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Posted 9 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed Electric Field Energy Ablation | Experimental | Procedure: Pulsed Electric Field AblationAblation of ganglionated plexi (GP) structures on the epicardial surface of the heart delivered as a concomitant procedure during open heart surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (26 listed)
- • Previous cardiac surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electric Field AblationCatheter ablation of Ganglionated Plexi (GP) structures on the epicardial surface of the heart during cardiothoracic surgery | Procedure or surgery | Pulsed Electric Field Energy Ablation |
Primary outcome
Number of Participants With Device-related Primary Safety Adverse Events
Time frame: 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
Number of Participants in Which Pulsed Electric Field Was Successfully Delivered to All Target Sites on the Epicardial Surface of the Heart.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37561246Musikantow 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry O'Brien, PhD study chair
AtriAN Medical
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electric Field Ablation in people with Atrial Fibrillation, run by Atrian Medical Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Device-related Primary Safety Adverse Events (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.