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CellFX® nsPFA™ for Atrial Fibrillation During Cardiac Surgery

This study is testing a new device called the CellFX® nsPFA™ Cardiac Surgery Clamp System to treat atrial fibrillation (a type of irregular heartbeat) during heart surgery. The goal is to see how safe and effective this device is. You might be able to join if you are between 18 and 85 years old, have a history of atrial fibrillation, and are having certain heart surgeries. The study will look at whether your atrial fibrillation goes away after the procedure and if there are any side effects. This study aims to enroll 135 participants.

Study design
This is a single-arm study, meaning all participants will receive the CellFX® nsPFA™ Cardiac Surgery System. It is planned to enroll 135 participants.
What's involved
You would need to provide informed consent and complete follow-up visits as outlined in the study plan. You would undergo a cardiac surgical procedure with the CellFX® nsPFA™ Cardiac Clamp.
Compensation
Not stated in the trial record.
Follow-up
Your freedom from atrial fibrillation will be measured from 3 to 6 months after the procedure. Adverse events will be monitored for 30 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06959121

CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation

Recruiting
NAAges 18–85InterventionalTreatment
Pulse Biosciences, Inc.
~135 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:CellFX® nsPFA™ Cardiac Surgery System

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from atrial fibrillation/atrial flutter/atrial tachycardia
Measured over 3-months through 6 months post-index procedure
+1 more outcome measured

Conditions

Atrial Fibrillation
Maze Procedure
AF
Ablation

Explore related trials

Atrial Fibrillation

NCT06959121

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Adventist Heart Institute: Adventist Health St. Helena

    St. Helena, Californiastudy coordinator listed

    Recruiting

  • Cardiac Surgery Clinic | Frankel Cardiovascular Center

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • Orlando Health

    Orlando, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Matthew A. Romano, MD · PRINCIPAL_INVESTIGATOR · University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center

Who to contact

Shweta Kalpa, MD
[email protected]
(800) 543-3695
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

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
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

What this trial measures

  • Freedom from atrial fibrillation/atrial flutter/atrial tachycardia3-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 EventsWithin 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).