Atrial Fibrillation ParoxysmalNANOPULSE-AFNCT07018596
NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System
A study testing CellFX nsPFA Cardiac Catheter System in people with Atrial Fibrillation Paroxysmal and Cardiac Ablation, run by Pulse Biosciences, Inc. at 1 site in Czechia.
Trial summary
The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation Paroxysmal, Cardiac Ablation, Cardiac Arrhythmia
- What is being tested?
- CellFX nsPFA Cardiac Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Apr 2026to Jan 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of recurrent drug-resistant symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:
- Physician's note indicating the presence of AF symptoms and at least two (2) episodes of self-terminating AF within six (6) months prior to enrollment
- Age 18 through 85 years old (or older than 18 if required by local law)
- Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD.
- Participant is willing and capable of providing Informed Consent
- Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators
Who cannot join
- Left atrial diameter ≥5.5 cm (anteroposterior)
- Any of the following within 3 months prior to enrollment:
- Any cardiac surgery
- Myocardial infarction
- Percutaneous Coronary Intervention (PCI) / Percutaneous Coronary Intervention (PTCA) or coronary artery stenting
- Unstable angina
Show all 38Show fewer
- Pericarditis or symptomatic pericardial effusion
- Any of the following within 6 months prior to enrollment:
- Any cerebral ischemic event (stroke or transient ischemic attack (TIA)
- History of thromboembolic event
- Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion)
- Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period
- Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- Documented left atrial (LA) thrombus by imaging within 48 hours of the procedure.
- Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
- Prior diagnosis of pulmonary vein stenosis
- Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- Moderate to severe mitral valve stenosis
- More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)
- New York Heart Association (NYHA) Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured by acceptable cardiac testing (e.g., TTE)
- History of pulmonary hypertension with pulmonary systolic artery pressure >50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease
- Rheumatic heart disease
- Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
- Active systemic infection
- Hypertrophic or advanced infiltrative cardiomyopathy
- Atrial myxoma
- Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
- History of abnormal bleeding and/or clotting disorder
- Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- History of severe chronic gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and/or alcohol addiction, congenital disease, fragility)
- Body Mass Index (BMI) > 40.0
- Participants 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
- Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor
- Unwilling or unable to comply fully with study procedures and follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Na Homolce Hospital
Prague, Roentgenova, 37/2
Štěpán Královec
Petr Neuzil, MD, PhD
About this study
Official title: Safety and Effectiveness of the CellFX® nsPFA Catheter Endocardial Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).
Read the detailed description
This study is a prospective, multicenter, non-randomized clinical investigation. Eligible participants with drug-resistant paroxysmal AF who are clinically indicated for a cardiac catheter ablation procedure will undergo nsPFA ablation with the CellFX Cardiac Catheter Ablation System. The primary endpoints will be assessed at 6 months after the ablation procedure.
- Being tested
- CellFX nsPFA Cardiac Catheter System
- Keywords
- nsPFA, 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 nsPFA Cardiac Catheter SystemDevice
The CellFX nsPFA Cardiac Catheter System includes the nsPFA 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 to treat arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nanosecond pulses of electrical energy. nsPFA 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 cell's and internal organelles' ability to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD).
| Study group | Role | What they receive |
|---|---|---|
| nsPFA Cardiac Catheter System Treatment Arm | Experimental | Nanosecond Pulsed Field Ablation (nsPFA) technology will be used for ablating cardiac tissue using the CellFX nsPFA Cardiac Catheter System Receives: Device: CellFX nsPFA Cardiac Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with freedom from primary safety endpoint
The primary safety endpoint is freedom from a primary safety endpoint for the following:
- Cerebrovascular accident/Stroke
- Thromboembolism
- Myocardial infarction
- Severe Pericarditis (requiring intervention)
- Transient ischemic attack
- Vagal nerve injury resulting in esophageal dysmotility or gastroparesis
- Major vascular access complications
- Bleeding
- Pulmonary edema
- Heart Block
- Permanent Phrenic Nerve paralysis
- Device or Procedure-related Death
- CellFX System-related or PFA procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalization for more than 48 hours, excluding recurrent atrial fibrillation/atrial flutter/atrial tachycardia (AF/AFL/AT)
- Cardiac tamponade/perforation
- Significant acute kidney injury secondary to hemolysis
- Pulmonary vein stenosis
- Esophageal perforating complications
Measured: Within 7 days, 30 days, and 6 months post-ablation procedure
Proportion of participants achieving freedom from treatment failure.
Acute procedural failure is defined as the inability to isolate all targeted pulmonary veins (PV) (minimally assessed for entrance block and, where assessable, exit block) during the index procedure or PV ablation using a non-study device in the left atrium
Measured: 6 months post-ablation
Secondary outcomes (1)
Proportion of participants achieving acute procedural success
Acute Procedural Success: Ability to isolate all pulmonary veins and no ablation using a non-study device in the left atrium.
Measured: Immediately 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 posted12 Jun 2025
- Study start6 Apr 2026
- Primary completionOct 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kenigsberg, MD, Study chair, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018596
- Sponsor's protocol ID
- NP-CCP-US-043
- Acronym
- NANOPULSE-AF
- Status last verified
- May 2026
- First submitted
- 5 Jun 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the CellFX® nsPFA Catheter Endocardial Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07018596
- Acronym / sponsor ID
- NANOPULSE-AF / NP-CCP-US-043
- Keywords
- nsPFA, Pulsed Field Ablation, nano-PFA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 Jun 2025 (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 the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).
Detailed description
This study is a prospective, multicenter, non-randomized clinical investigation. Eligible participants with drug-resistant paroxysmal AF who are clinically indicated for a cardiac catheter ablation procedure will undergo nsPFA ablation with the CellFX Cardiac Catheter Ablation System. The primary endpoints will be assessed at 6 months after the ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nsPFA Cardiac Catheter System Treatment Arm | Experimental | Device: CellFX nsPFA Cardiac Catheter SystemNanosecond Pulsed Field Ablation (nsPFA) technology will be used for ablating cardiac tissue using the CellFX nsPFA Cardiac Catheter System |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of recurrent drug-resistant symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:
- Age 18 through 85 years old (or older than 18 if required by local law)
- Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD.
- Participant is willing and capable of providing Informed Consent
- Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators
Key exclusion criteria (38 listed)
- Left atrial diameter ≥5.5 cm (anteroposterior)
- Any of the following within 3 months prior to enrollment:
- Any of the following within 6 months prior to enrollment:
- Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion)
- Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period
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 nsPFA Cardiac Catheter SystemThe CellFX nsPFA Cardiac Catheter System includes the nsPFA 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 to treat arrhythmias, including atrial fibrillation. The nano-PFA 360 Catheter ablates cardiac tissue using nonthermal nanosecond pulses of electrical energy. nsPFA 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 cell's and internal organelles' ability to maintain cellular homeostasis by creating nanopores in lipid membranes, ultimately leading to regulated cell death (RCD). | Device | nsPFA Cardiac Catheter System Treatment Arm |
Primary outcome
Proportion of participants with freedom from primary safety endpoint
Time frame: Within 7 days, 30 days, and 6 months post-ablation procedure
The primary safety endpoint is freedom from a primary safety endpoint for the following: * Cerebrovascular accident/Stroke * Thromboembolism * Myocardial infarction * Severe Pericarditis (requiring intervention) * Transient ischemic attack * Vagal nerve injury resulting in esophageal dysmotility or gastroparesis * Major vascular access complications * Bleeding * Pulmonary edema * Heart Block * Permanent Phrenic Nerve paralysis * Device or Procedure-related Death * CellFX System-related or PFA procedure-related cardiovascular and/or pulmonary adverse event that prolongs or requires hospitalization for more than 48 hours, excluding recurrent atrial fibrillation/atrial flutter/atrial tachycardia (AF/AFL/AT) * Cardiac tamponade/perforation * Significant acute kidney injury secondary to hemolysis * Pulmonary vein stenosis * Esophageal perforating complications
Proportion of participants achieving freedom from treatment failure.
Time frame: 6 months post-ablation
Acute procedural failure is defined as the inability to isolate all targeted pulmonary veins (PV) (minimally assessed for entrance block and, where assessable, exit block) during the index procedure or PV ablation using a non-study device in the left atrium
1 secondary outcome
Proportion of participants achieving acute procedural success
Time frame: Immediately 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 6 May 2026.
- 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.
David Kenigsberg, MD study chair
Pulse Biosciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX nsPFA Cardiac Catheter System in people with Atrial Fibrillation Paroxysmal and Cardiac Ablation, run by Pulse Biosciences, Inc. at 1 site in Czechia.
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 6 inclusion and 38 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 6 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 1 site in Czechia. 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 Micki Weisman (510-906-4649, micki.weisman@pulsebiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with freedom from primary safety endpoint (time frame: Within 7 days, 30 days, and 6 months 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?
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 6 May 2026.