Atrial FibrillationNCT06355063
CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
A study testing CellFX® nsPFA™ Cardiac Surgery System in people with Atrial Fibrillation and Surgery, run by Pulse Biosciences, Inc. at 6 sites in 3 countries.
Trial summary
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Surgery, Ablation of Atrial Fibrillation
- What is being tested?
- CellFX® nsPFA™ Cardiac Surgery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 31 Jul 2024to 31 Dec 2027
- 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
- Subject must be between 18 and 85 years of age
- Subject is willing and capable of providing Informed Consent to undergo study procedures which includes surgical AF ablation and completing follow-up visits as specified in the clinical study protocol
- Subject has history of documented atrial fibrillation within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), holter monitor or telemetry strip
- Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, or Coronary artery bypass procedures
- Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
- Subject has a life expectancy of at least 5 years
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
- Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- Previous surgical Maze procedure
- Prior cardiac surgery (Redo)
- Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
Show all 30Show fewer
- Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair.
- Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
- Class IV New York Heart Association (NYHA) heart failure symptoms
- Prior history of cerebrovascular accident or TIA within 6 months or at any time if there is residual neurological deficit
- Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (i.e., cardiogenic shock)
- Known carotid artery stenosis greater than 80%
- Current diagnosis of active systemic infection
- Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
- Renal failure requiring dialysis or hepatic failure
- A known drug and/or alcohol addiction
- Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
- Pregnancy or desire to get pregnant within 12-months of the study treatment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Subjects who have been treated with thoracic radiation
- Subjects in current chemotherapy
- Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
- Subjects with known hypertrophic obstructive cardiomyopathy
- Subjects with known cold agglutinin
- History of abnormal bleeding and/or clotting disorder
- Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Body mass index > 40 kg/m2
- Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Netherlands4 sites, 2 recruiting
- Active, not recruiting
Academic Medical Center
Amsterdam
- Recruiting
Catharina Hospital
Eindhoven
N.J. (Niels) Verberkmoes, MD
- Active, not recruiting
Maastricht University Medical Center+ (MUMC+)
Maastricht
- Recruiting
St. Antonius Hospital
Nieuwegein
Bart van Putte, MD, PhD
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Prof. Marek Ehrlich, M.D., Ph.D
Emilio Osario, MD
Poland1 site, 1 recruiting
- Recruiting
State Medical Institute of the Ministry of Interior Affairs and Administration
Warsaw
Prof. Dr. Piotr Suwalski, M.D. Ph.D
About this study
Official title: Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.
Read the detailed description
This study is a prospective, multicenter, single arm, non-randomized, feasibility study. Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall
- Being tested
- CellFX® nsPFA™ Cardiac Surgery System
- Keywords
- CellFX, nsPFA Cardiac Surgery System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX® nsPFA™ Cardiac Surgery SystemDevice
Adult patients presenting to the investigational center that are to undergo non-emergent concomitant cardiac surgical procedure(s), scheduled to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, ascending aortic aneurysms, or coronary artery bypass procedures with history of documented atrial fibrillation within one year prior to enrollment will be evaluated for eligibility and participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| CellFX nsPFA Treatment Arm | Experimental | Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box using the CellFX® nsPFA™ Cardiac Surgery System. Receives: Device: CellFX® nsPFA™ Cardiac Surgery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute major adverse events (MAEs)
Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding.
Measured: Within 30 days post-ablation procedure
Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box
The ablation procedure includes pulmonary vein isolation and a series of ablation lines to create a "box lesion" on the posterior left atrial free wall. At the conclusion of both the primary and concomitant procedures, exit and/or entrance block will be performed to confirm complete isolation of the pulmonary veins and the left atrial posterior wall.
Measured: Within 24 hours post-ablation procedure
Secondary outcomes (2)
Proportion of Participants with one or more SAEs
Long-term safety endpoint for the incidence of treatment-emergent adverse events [Safety and Tolerability] for subjects having one or more SAEs at each follow-up interval.
Measured: Up to 12-months post-procedure
Number of Participants with Long-Term Technical Success
Long-term Technical Success of the Pulse Biosciences CellFX® nsPFA™ Cardiac Surgery System is defined as participants having confirmation of electrical isolation of the bilateral pulmonary veins and left atrial box by cardiac electroanatomical mapping 2-6 months post-ablation procedure.
Measured: 60-120 days following the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start31 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- This study is a prospective, multicenter, single arm, non-randomized, feasibility study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Rich Nuccitelli, PhD, Study director, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355063
- Sponsor's protocol ID
- NP-PCF-037
- Other IDs
- NCT06355063
- Status last verified
- Jan 2026
- First submitted
- 1 Apr 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06355063
- Acronym / sponsor ID
- NP-PCF-037
- Keywords
- CellFX, nsPFA Cardiac Surgery System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Apr 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.
This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure.
Detailed description
This study is a prospective, multicenter, single arm, non-randomized, feasibility study. Adult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box. All subjects will return to the hospital between 60-120 days post-surgical ablation procedure to undergo a cardiac electrophysiology study with electroanatomical mapping to assess electrical isolation of the pulmonary veins and left atrial posterior wall
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, multicenter, single arm, non-randomized, feasibility study.
| Arm | Type | Receives |
|---|---|---|
| CellFX nsPFA Treatment Arm | Experimental | Device: CellFX® nsPFA™ Cardiac Surgery SystemAdult subjects who are clinically indicated for a concomitant cardiac surgical procedure will undergo left pulmonary vein, roof and floor ablations to form a left atrial posterior box using the CellFX® nsPFA™ Cardiac Surgery 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)
- Subject must be between 18 and 85 years of age
- Subject is willing and capable of providing Informed Consent to undergo study procedures which includes surgical AF ablation and completing follow-up visits as specified in the clinical study protocol
- Subject has history of documented atrial fibrillation within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), holter monitor or telemetry strip
- Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, or Coronary artery bypass procedures
- Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
Key exclusion criteria (30 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
- Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- Previous surgical Maze procedure
- Prior cardiac surgery (Redo)
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 Surgery SystemAdult patients presenting to the investigational center that are to undergo non-emergent concomitant cardiac surgical procedure(s), scheduled to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, ascending aortic aneurysms, or coronary artery bypass procedures with history of documented atrial fibrillation within one year prior to enrollment will be evaluated for eligibility and participation in the study. | Device | CellFX nsPFA Treatment Arm |
Primary outcome
Rate of acute major adverse events (MAEs)
Time frame: Within 30 days post-ablation procedure
Acute major adverse events (MAEs) include, cardiac death, stroke, myocardial infarction, transient ischemic attack, or excessive bleeding.
Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial box
Time frame: Within 24 hours post-ablation procedure
The ablation procedure includes pulmonary vein isolation and a series of ablation lines to create a "box lesion" on the posterior left atrial free wall. At the conclusion of both the primary and concomitant procedures, exit and/or entrance block will be performed to confirm complete isolation of the pulmonary veins and the left atrial posterior wall.
2 secondary outcomes
Proportion of Participants with one or more SAEs
Time frame: Up to 12-months post-procedure
Number of Participants with Long-Term Technical Success
Time frame: 60-120 days following the index 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 12 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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.
Rich Nuccitelli, PhD study director
Pulse Biosciences, Inc.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX® nsPFA™ Cardiac Surgery System in people with Atrial Fibrillation and Surgery, run by Pulse Biosciences, Inc. at 6 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 6 inclusion and 30 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 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, Austria, Poland. 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 (+1 (919) 757-2033, 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 acute 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?
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 12 Jan 2026.