Atrial Fibrillation ParoxysmalNCT06696170
CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation
A study testing CellFX nano-pFA 360 Endocardial Ablation Catheter System in people with Atrial Fibrillation Paroxysmal and Cardiac Ablation, run by Pulse Biosciences, Inc. at 3 sites in 3 countries.
Trial summary
The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- What is being tested?
- CellFX nano-pFA 360 Endocardial Ablation Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 25 Jul 2024to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment
- Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study
- Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
- Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents
- Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure
- Left ventricular ejection fraction ≥ 40% as documented by TTE within 12 months prior to the procedure
- Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by the study investigators
Who cannot join
- Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
- Subject has a prosthetic heart valve
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- AF episodes lasting > 7 days
- Previous ablation for AF
- Subjects on amiodarone at any time during the past 3 months prior to enrollment
Show all 33Show fewer
- Prior history of pericarditis or pericarditis within 3 months based on the TTE examination
- Prior history of rheumatic fever
- Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, left atrial appendage occlusion)
- History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- History of abnormal bleeding and/or clotting disorder
- Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as Warfarin)
- Active malignancy or history of treated cancer within 24 months of enrollment
- Clinically significant infection or sepsis on the day of index procedure with either fever, leukocytosis or requiring intravenous antibiotics
- History of stroke or TIA within prior 6 months, or any prior intracranial hemorrhage or permanent neurological deficit
- New York Heart Association (NYHA) class IIIb or IV congestive heart failure and/or any heart failure hospitalization within 3 months prior to enrollment
- Body mass index > 35 kg/m2
- Estimate glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 or has ever received hemodialysis
- History of untreated and serious hypotension, bradycardia or chronotropic incompetence
- Any of the following within 3 months of enrollment:
- Major surgery except for the index procedure
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Sudden cardiac death event
- Left atrial thrombus that has not resolved as shown by TEE or CT
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- History of pulmonary hypertension with pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease
- Subjects with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)
- Life expectancy less than one year
- Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
- Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period
- Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Belgium1 site
- Active, not recruiting
Hartcentrum Hasselt Research Center /Jessa Hospital
Hasselt
Czechia1 site, 1 recruiting
- Recruiting
Na Homolce Hospital
Prague
Štěpán Královec
Prof. Petr Neuzil, MD, PhD
Italy1 site, 1 recruiting
- Recruiting
Policlinico Tor Vergata Hospital
Roma
Giuseppe Stifano, MD, PhD
Prof. Andrea Natale, MD
About this study
Official title: Initial Safety and Performance of the CellFX® Nano-PFA 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation
The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.
Read the detailed description
This study is a prospective, non-randomized, open labelled, single-arm first-in-human (FIH) feasibility study to evaluate the initial clinical safety and device performance of the nano-PFA 360 Catheter Endocardial Ablation System for the treatment of atrial fibrillation. Enrolled subjects will be followed for up to 12 months post-nano PFA 360 Catheter Ablation. All subjects will undergo an electroanatomical mapping procedure post-ablation to evaluate immediate pulmonary vein isolation (PVI) and at 3 months post-index procedure to assess electrical isolation of the pulmonary veins.
- Being tested
- CellFX nano-pFA 360 Endocardial Ablation Catheter System
- Keywords
- nsPFA, CellFX, Pulsed Field Ablation, nano-PFA
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX nano-pFA 360 Endocardial Ablation Catheter SystemDevice
The CellFX nano-PFA 360 Endocardial Ablation Catheter System includes the nano-pFA 360 Endocardial Ablation Catheter, CellFX Console, switcher box/adapter, and sensing cable. The System is a proprietary endocardial catheter system designed for use in cardiac electrophysiology procedures for the treatment of arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nano-second pulses of electrical energy. Nanosecond Pulsed Field Ablation (nsPFA or nano-PFA) is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses disrupt the ability of the cell and internal organelles to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).
| Study group | Role | What they receive |
|---|---|---|
| CellFX nano-PFA Treatment Arm | Experimental | CellFX nano-PFA 360 Endocardial Ablation Catheter System Receives: Device: CellFX nano-pFA 360 Endocardial Ablation Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of primary safety major adverse events (MAEs)
The primary safety endpoint includes major adverse events (MAEs) specifically related to the device or ablation procedure for the following
- Asymptomatic Cerebral Embolism
- Arterioesophageal Fistula
- Bleeding Requiring Transfusion
- Cardiac Perforation/Tamponade
- Death
- Esophageal Injury Resulting in Perforation
- Myocardial Infarction
- Pericarditis Requiring Intervention or Hospitalization
- Phrenic Nerve Injury/Diaphragmatic Paralysis
- Pulmonary Edema/Respiratory Insufficiency
- Pulmonary Vein Stenosis (≥70% diameter reduction)
- Stroke or Transient Ischemic Attack
- Vagal Nerve Injury Resulting in Esophageal Dysmotility or Gastroparesis
- Vascular Access Complication Requiring Intervention
Measured: Within 30 days post-ablation procedure
Proportion of participants achieving acute procedural success.
Acute procedural success is achieving entrance block of the pulmonary veins
Measured: Immediately post-ablation procedure
Secondary outcomes (3)
Proportion of participants reporting one or more significant adverse events (SAEs)
Safety related to the reporting one or more SAEs for each follow-up interval as described.
- Atrio-esophageal fistula (up to 3-month visit)
- Pulmonary Vein (PV) stenosis (up to 3-month visit)
- Subjects presenting with Primary SAEs up to the 12-month post- procedure follow-up
- Subjects presenting with any AEs or SAEs up to the 12-month post- procedure follow-up
Measured: Within 12 months post-ablation procedure
Proportion of participants achieving long-term technical success
Long-term technical success is defined as electrical isolation of the pulmonary veins (PVI) assessed during an electroanatomical mapping procedure.
Measured: Within 3 months post-ablation procedure
Proportion of participants achieving treatment success
Treatment success is defined by freedom from the following failures:
- Recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 secs on transtelephonic monitoring (TTM), Holter monitoring, or continuously 12-lead electrocardiogram (ECG)
- Cardioversion for atrial fibrillation (AF) /atrial flutter (AFL) / atrial tachycardia (AT)
- Repeat ablation failure
- Antiarrhythmic Drugs (AADs) failure
- Surgical treatment for AF/AFL/AT after the index procedure
Measured: Within 12 months post-ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start25 Jul 2024
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation ParoxysmalStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rich A. Nuccitelli, PhD, Study director, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696170
- Sponsor's protocol ID
- NP-CCF-033
- Status last verified
- May 2026
- First submitted
- 18 Nov 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reddy VY, Petru J, Vijgen J, Turagam M, Koruth JS, Funasako M, Hala P, Koopman P, Skoda J, Stifano G, La Fazia MV, Kenigsberg D, Natale A, Neuzil P. High-Voltage Nanosecond Pulse Field Ablation Using a Compliant Circular Catheter to Treat Atrial Fibrillation: Lesion Durability and One-Year Outcomes. JACC Clin Electrophysiol. 2026 Apr 25:S2405-500X(26)00367-1. doi: 10.1016/j.jacep.2026.04.012. Online ahead of print.
PubMed 42175980
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Safety and Performance of the CellFX® Nano-PFA 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06696170
- Acronym / sponsor ID
- NP-CCF-033
- Keywords
- nsPFA, CellFX, Pulsed Field Ablation, nano-PFA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jul 2026 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.
Detailed description
This study is a prospective, non-randomized, open labelled, single-arm first-in-human (FIH) feasibility study to evaluate the initial clinical safety and device performance of the nano-PFA 360 Catheter Endocardial Ablation System for the treatment of atrial fibrillation. Enrolled subjects will be followed for up to 12 months post-nano PFA 360 Catheter Ablation. All subjects will undergo an electroanatomical mapping procedure post-ablation to evaluate immediate pulmonary vein isolation (PVI) and at 3 months post-index procedure to assess electrical isolation of the pulmonary veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CellFX nano-PFA Treatment Arm | Experimental | Device: CellFX nano-pFA 360 Endocardial Ablation Catheter SystemCellFX nano-PFA 360 Endocardial Ablation Catheter System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment
- Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study
- Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip
- Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents
- Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure
Key exclusion criteria (33 listed)
- Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device
- Subject has a prosthetic heart valve
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- AF episodes lasting > 7 days
- Previous ablation for AF
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 |
|---|---|---|
| CellFX nano-pFA 360 Endocardial Ablation Catheter SystemThe CellFX nano-PFA 360 Endocardial Ablation Catheter System includes the nano-pFA 360 Endocardial Ablation Catheter, CellFX Console, switcher box/adapter, and sensing cable. The System is a proprietary endocardial catheter system designed for use in cardiac electrophysiology procedures for the treatment of arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nano-second pulses of electrical energy. Nanosecond Pulsed Field Ablation (nsPFA or nano-PFA) is a cell-specific, nonthermal ablation technology that delivers nanosecond-duration pulses of high-amplitude electrical energy to tissue via bipolar electrodes. The pulses disrupt the ability of the cell and internal organelles to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD). | Device | CellFX nano-PFA Treatment Arm |
Primary outcome
Rate of primary safety major adverse events (MAEs)
Time frame: Within 30 days post-ablation procedure
The primary safety endpoint includes major adverse events (MAEs) specifically related to the device or ablation procedure for the following * Asymptomatic Cerebral Embolism * Arterioesophageal Fistula * Bleeding Requiring Transfusion * Cardiac Perforation/Tamponade * Death * Esophageal Injury Resulting in Perforation * Myocardial Infarction * Pericarditis Requiring Intervention or Hospitalization * Phrenic Nerve Injury/Diaphragmatic Paralysis * Pulmonary Edema/Respiratory Insufficiency * Pulmonary Vein Stenosis (≥70% diameter reduction) * Stroke or Transient Ischemic Attack * Vagal Nerve Injury Resulting in Esophageal Dysmotility or Gastroparesis * Vascular Access Complication Requiring Intervention
Proportion of participants achieving acute procedural success.
Time frame: Immediately post-ablation procedure
Acute procedural success is achieving entrance block of the pulmonary veins
3 secondary outcomes
Proportion of participants reporting one or more significant adverse events (SAEs)
Time frame: Within 12 months post-ablation procedure
Proportion of participants achieving long-term technical success
Time frame: Within 3 months post-ablation procedure
Proportion of participants achieving treatment success
Time frame: Within 12 months post-ablation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 42175980Reddy VY, Petru J, Vijgen J, Turagam M, Koruth JS, Funasako M, Hala P, Koopman P, Skoda J, Stifano G, La Fazia MV, Kenigsberg D, Natale A, Neuzil P. High-Voltage Nanosecond Pulse Field Ablation Using a Compliant Circular Catheter to Treat Atrial Fibrillation: Lesion Durability and One-Year Outcomes. JACC Clin Electrophysiol. 2026 Apr 25:S2405-500X(26)00367-1. doi: 10.1016/j.jacep.2026.04.012. Online ahead of print.
- 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.
Rich A. Nuccitelli, PhD study director
Pulse Biosciences, Inc.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX nano-pFA 360 Endocardial Ablation Catheter System in people with Atrial Fibrillation Paroxysmal and Cardiac Ablation, run by Pulse Biosciences, Inc. at 3 sites in 3 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 7 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Czechia, Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William A. Knape (510-906-4649, bknape@pulsebiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of primary safety major adverse events (MAEs) (time frame: Within 30 days post-ablation procedure). 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 NCT06696170, 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 5 May 2026.