NCT06959121 CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
| NCT ID | NCT06959121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pulse Biosciences, Inc. |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2025-10-23 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Matthew A. Romano, MD
PRINCIPAL INVESTIGATOR
University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center
Frequently Asked Questions
Who can join the NCT06959121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06959121 currently recruiting?
Yes, NCT06959121 is actively recruiting participants. Contact the research team at Shweta.Kalpa@pulsebiosciences.com for enrollment information.
Where is the NCT06959121 trial being conducted?
This trial is being conducted at St. Helena, United States, Ann Arbor, United States.
Who is sponsoring the NCT06959121 clinical trial?
NCT06959121 is sponsored by Pulse Biosciences, Inc.. The principal investigator is Matthew A. Romano, MD at University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center. The trial plans to enroll 135 participants.
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