CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation, Maze Procedure, AF, Ablation
In brief
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.
Key facts
- Study ID
- NCT06959121
- Run by
- Pulse Biosciences, Inc.
- People needed
- 135
- Starts
- 2025-10-23
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Adventist Heart Institute: Adventist Health St. Helena — St. Helena, California, United States (enrolling)
- Cardiac Surgery Clinic | Frankel Cardiovascular Center — Ann Arbor, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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