Atrial FibrillationNANOCLAMP-AFNCT06959121
CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
A study testing CellFX® nsPFA™ Cardiac Surgery System in people with Atrial Fibrillation and Maze Procedure, run by Pulse Biosciences, Inc. at 3 sites in United States.
Trial summary
The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation, Maze Procedure, AF
- 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
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Oct 2025to Dec 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
- Subject must be between 18 and 85 years of age
- Subject is willing and capable of providing Informed Consent to undergo study procedures which include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study protocol
- Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent/longstanding persistent atrial fibrillation (AF that is continuous and sustains for > 7 days and requires intervention) within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor or telemetry strip from the study hospital or an outside physician
- Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery via sternotomy for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, Atrial Septal Defect (ASD)/Patent Foramen Ovale (PFO) 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
- Subject currently lives within a reasonable commuting distance of the investigational site and plans to remain geographically stable through 12 month follow up
Who cannot join
- Subject has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter-defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) or left atrial appendage (LAA) device
- Subject has history or known to have LAA clot
- Subject has a prosthetic heart valve
- Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- Prior cardiac surgery including prior cardiac surgical ablation
- Left Atrial diameter ≥ 6cm
Show all 35Show fewer
- Wolff-Parkinson-White syndrome or other Supra-Ventricular Arrhythmia, Atrioventricular (AV) nodal reentry
- Documented history of persistent or long standing persistent atrial fibrillation longer than 10 years
- Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair/PFO and ascending aorta
- Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)
- Subjects that are on an AAD for ventricular arrhythmia.
- STS Predicted Risk of Mortality (STS PROM) of 10 or higher
- Class III or IV New York Heart Association (NYHA) heart failure symptoms
- Prior history of stroke within 6 months
- Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
- Need for emergent cardiac surgery (per sit-to-stand (STS) test definition)
- 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 (significant liver dysfunction with markedly significant elevation of liver enzymes, such as cirrhosis with decompensation, portal hypertension, or a history of hepatic failure)
- A known drug and/or alcohol addiction
- Mental impairment or other conditions that 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
- Subject has a contraindication to anticoagulation (e.g., a bleeding or clotting disorder such as Idiopathic Thrombocytopenic Purpura (ITP))
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Body mass index > 45 kg/m2
- Any diagnosed connective tissue disorder
- Severe Chronic Obstructive Pulmonary Disease (COPD) per sit-to-stand (STS) test definition
- Use of any other investigational drug, therapy, or device within 30 days before enrollment or concurrent participation in another research study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cardiac Surgery Clinic | Frankel Cardiovascular Center
Ann Arbor, Michigan, 48109
Matthew A Romano, MD, 888-287-1082
- Recruiting
Orlando Health
Orlando, Florida, 32806
Anthony Rongione, MD, 321-841-6444, anthony.rongione@orlandohealth.com
- Recruiting
Adventist Heart Institute: Adventist Health St. Helena
St. Helena, California, 94574
Aaron M Kime, MD, 707-963-7200
About this study
Official title: Pulse Biosciences' CellFX nsPFA Cardiac Surgery Clamp System for the Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery
The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
Read the detailed description
The study design is a prospective, multicenter, non-randomized single arm study. Eligible adult subjects with paroxysmal or persistent/longstanding persistent AF who are eligible to participate will undergo a concomitant cardiac surgical procedure with CellFX nsPFA Cardiac Surgery System ablation and left atrial appendage exclusion or removal. The left atrial wall isolation will include left and right pulmonary vein isolation as well as isolation of the left atrial posterior wall through left atrial roof and floor lesions. The left atrial posterior wall isolation (PWI) can be formed by either allowing a closed LA epicardial only lesion encompassing the entire posterior wall of the left atrium or by a combined epicardial/endocardial approach when the left atrium is open.
Primary effectiveness endpoint is freedom from any AF/AFL/AT lasting > 30 seconds and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias following the 90-day blanking period through 6 months post the concomitant surgical and ablation procedure by a core lab.
Primary safety endpoint is the incidence of acute major adverse events (MAEs), which includes death, stroke, myocardial infarction (MI), transient ischemic attack (TIA), or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4, or 5) within 30 days post-concomitant surgical procedure. These events may be related to either the cardiac surgical procedure or the ablation procedure. All MAE events will be reviewed and adjudicated by an independent Clinical Events Committee (CEC).
- Conditions
- Atrial Fibrillation, Maze Procedure, AF, Ablation
- Being tested
- CellFX® nsPFA™ Cardiac Surgery System
- Keywords
- nsPFA
- 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
Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp
| Study group | Role | What they receive |
|---|---|---|
| CellFX nsPFA Clamp | Experimental | Adult subjects who are eligible to participate will undergo a concomitant cardiac surgical procedure with nsPFA ablation (of left and right pulmonary veins as well as roof and floor lesions to form a box) and treatment of left atrial appendage. Receives: Device: CellFX® nsPFA™ Cardiac Surgery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Freedom from AF/AFL/AT of 30 seconds or greater duration and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias.
Measured: 3-months through 6 months post-index procedure
Incidence of Treatment-Emergent Adverse Events
Rate of acute major adverse events (MAEs) which includes death, stroke, myocardial infarction (MI), and transient ischemic attack (TIA) or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4 or 5).
Measured: Within 30 days post-concomitant surgical procedure
Secondary outcomes (3)
Acute electrical isolation of the pulmonary veins
Acute electrical isolation of the left and right pulmonary veins and left atrial posterior wall by means of either intraoperative entrance or exit block testing
Measured: Immediately post-ablation procedure
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Freedom from AF/AFL/AT of 30 seconds and freedom from use of new or increased dose of previously failed Class I or III AADs prescribed to treat atrial arrhythmias
Measured: Within 12 months post-ablation procedure
Patient-Reported Outcome Measures (PROMs) for quality of life assessing well-being across physical, mental, and social domains
Quality of Life (QoL) as measured using AFEQT and SF-12 (Physical Component Summary (PCS), Mental Component Summary (MCS) and General Health (GH))
Measured: 6 and 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 posted6 May 2025
- Study start23 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completionDec 2028 (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
- Single-Arm Study.
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Matthew A. Romano, MD, Principal investigator, University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959121
- Sponsor's protocol ID
- NP-PCP-041
- Acronym
- NANOCLAMP-AF
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2025
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Biosciences' CellFX nsPFA Cardiac Surgery Clamp System for the Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06959121
- Acronym / sponsor ID
- NANOCLAMP-AF / NP-PCP-041
- Conditions
- Atrial Fibrillation, Maze Procedure, AF, Ablation
- Keywords
- nsPFA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 May 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 primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
Detailed description
The study design is a prospective, multicenter, non-randomized single arm study. Eligible adult subjects with paroxysmal or persistent/longstanding persistent AF who are eligible to participate will undergo a concomitant cardiac surgical procedure with CellFX nsPFA Cardiac Surgery System ablation and left atrial appendage exclusion or removal. The left atrial wall isolation will include left and right pulmonary vein isolation as well as isolation of the left atrial posterior wall through left atrial roof and floor lesions. The left atrial posterior wall isolation (PWI) can be formed by either allowing a closed LA epicardial only lesion encompassing the entire posterior wall of the left atrium or by a combined epicardial/endocardial approach when the left atrium is open.
Primary effectiveness endpoint is freedom from any AF/AFL/AT lasting > 30 seconds and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias following the 90-day blanking period through 6 months post the concomitant surgical and ablation procedure by a core lab.
Primary safety endpoint is the incidence of acute major adverse events (MAEs), which includes death, stroke, myocardial infarction (MI), transient ischemic attack (TIA), or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4, or 5) within 30 days post-concomitant surgical procedure. These events may be related to either the cardiac surgical procedure or the ablation procedure. All MAE events will be reviewed and adjudicated by an independent Clinical Events Committee (CEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-Arm Study.
| Arm | Type | Receives |
|---|---|---|
| CellFX nsPFA Clamp | Experimental | Device: CellFX® nsPFA™ Cardiac Surgery SystemAdult subjects who are eligible to participate will undergo a concomitant cardiac surgical procedure with nsPFA ablation (of left and right pulmonary veins as well as roof and floor lesions to form a box) and treatment of left atrial appendage. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 include the potential for surgical AF ablation, and completion of follow-up visits as specified in the clinical study protocol
- Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent/longstanding persistent atrial fibrillation (AF that is continuous and sustains for > 7 days and requires intervention) within one year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor or telemetry strip from the study hospital or an outside physician
- Subject is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery via sternotomy for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Ascending aortic aneurysms, Atrial Septal Defect (ASD)/Patent Foramen Ovale (PFO) 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 (35 listed)
- Subject has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter-defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) or left atrial appendage (LAA) device
- Subject has history or known to have LAA clot
- Subject has a prosthetic heart valve
- Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
- Prior cardiac surgery including prior cardiac surgical ablation
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 SystemParticipants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp | Device | CellFX nsPFA Clamp |
Primary outcome
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Time frame: 3-months through 6 months post-index procedure
Freedom from AF/AFL/AT of 30 seconds or greater duration and freedom for use of new or increased dose of previously failed Class I or III antiarrhythmic drugs (AADs) prescribed to treat atrial arrhythmias.
Incidence of Treatment-Emergent Adverse Events
Time frame: Within 30 days post-concomitant surgical procedure
Rate of acute major adverse events (MAEs) which includes death, stroke, myocardial infarction (MI), and transient ischemic attack (TIA) or excessive bleeding (Bleeding Academic Research Consortium (BARC) 3b, 4 or 5).
3 secondary outcomes
Acute electrical isolation of the pulmonary veins
Time frame: Immediately post-ablation procedure
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Time frame: Within 12 months post-ablation procedure
Patient-Reported Outcome Measures (PROMs) for quality of life assessing well-being across physical, mental, and social domains
Time frame: 6 and 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 9 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
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
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Matthew A. Romano, MD principal investigator
University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center
3 sites 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 Surgery System in people with Atrial Fibrillation and Maze Procedure, run by Pulse Biosciences, Inc. at 3 sites in United States.
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 35 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 9 Sep 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 United States. 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 Shweta Kalpa, MD ((800) 543-3695, Shweta.Kalpa@pulsebiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia (time frame: 3-months through 6 months post-index 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 9 Sep 2026.