Tests a device for treating atrial fibrillation during heart surgery
Tests the CellFX nsPFA heart clamp to treat atrial fibrillation in adults during surgery.
Plain-language title generated from the registry record
Registry title: CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation
Key facts
- Where
- Warsaw, PolandSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06355063, who can take part
Where in Poland
- State Medical Institute of the Ministry of Interior Affairs and AdministrationWarsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pulse Biosciences, Inc.
- Trial code
- NCT06355063
- Record updated
- 12 January 2026
- Original description
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 full original descriptionShow less
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.
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 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.
Exclusion: 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); Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation); 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; A known drug and/or alcohol addiction; 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); Solid organ or hematologic transplant, or currently being evaluated for an organ transplant; Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study; Subject has a prosthetic heart valve; Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry; Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or atrial septal defect repair; Class IV New York Heart Association (NYHA) heart failure symptoms; Need for emergent cardiac surgery (i.e., cardiogenic shock); Current diagnosis of active systemic infection; Severe peripheral arterial occlusive disease defined as claudication with minimal exertion; Renal failure requiring dialysis or hepatic failure; Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study; History of abnormal bleeding and/or clotting disorder; Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device; Known carotid artery stenosis greater than 80%; 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 with known hypertrophic obstructive cardiomyopathy; Subjects with known cold agglutinin; Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin); Body mass index > 40 kg/m2.