Atrial FibrillationNeural-AF-2NCT05426759
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
A study testing Pulsed Field Ablation of epicardial Ganglionated Plexi. in people with Atrial Fibrillation, run by Atrian Medical Ltd. at 1 site in Georgia.
Trial summary
A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation. 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 Field Ablation of epicardial Ganglionated Plexi.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGeorgia
- Study dates
- 1 Jun 2022to 30 Jun 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 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulsed Field Ablation of epicardial Ganglionated Plexi.
- 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 Field Ablation of epicardial Ganglionated Plexi.Device
Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.
| Study group | Role | What they receive |
|---|---|---|
| GP Ablation | Experimental | Single arm study with GP ablations performed during open-chest surgery Receives: Device: Pulsed Field Ablation of epicardial Ganglionated Plexi. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients in Sinus Rhythm at 12 Months.
Patients will be monitored with 24 hour Holter at 12 months
Measured: 12 month
Secondary outcomes (1)
Extension of AERP
The acute increase in atrial effective refractory period (AERP) i.e. by comparing AERP values from immediately before and immediately after ablation.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Jun 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrian Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426759
- Sponsor's protocol ID
- CIP-002
- Acronym
- Neural-AF-2
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2022
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Musikantow DR, Reddy VY, Shaburishvili T, van Zyl M, O'Brien B, Coffey K, Reilly J, Asirvatham S, de Groot JR. Epicardial Pulsed Field Ablation for the Treatment of Paroxysmal Atrial Fibrillation During Cardiac Surgery. JACC Clin Electrophysiol. 2024 Sep;10(9):2097-2099. doi: 10.1016/j.jacep.2024.06.012. Epub 2024 Jul 24. No abstract available.
PubMed 39066781
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05426759
- Acronym / sponsor ID
- Neural-AF-2 / CIP-002
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Atrian Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Posted 3 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GP Ablation | Experimental | Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.Single arm study with GP ablations performed during open-chest surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
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 Field Ablation of epicardial Ganglionated Plexi.Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart. | Device | GP Ablation |
Primary outcome
The Number of Patients in Sinus Rhythm at 12 Months.
Time frame: 12 month
Patients will be monitored with 24 hour Holter at 12 months
1 secondary outcome
Extension of AERP
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39066781Musikantow DR, Reddy VY, Shaburishvili T, van Zyl M, O'Brien B, Coffey K, Reilly J, Asirvatham S, de Groot JR. Epicardial Pulsed Field Ablation for the Treatment of Paroxysmal Atrial Fibrillation During Cardiac Surgery. JACC Clin Electrophysiol. 2024 Sep;10(9):2097-2099. doi: 10.1016/j.jacep.2024.06.012. Epub 2024 Jul 24. No abstract available.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Field Ablation of epicardial Ganglionated Plexi. in people with Atrial Fibrillation, run by Atrian Medical Ltd. at 1 site in Georgia.
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 5 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 3 Jul 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?
The Number of Patients in Sinus Rhythm at 12 Months. (time frame: 12 month). 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 NCT05426759, 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 3 Jul 2024.