[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"af\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:af":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100589800","cellfx-nanosecond-pulsed-field-ablation-nspfa-cardiac-surgery-clamp-system-to-treat-atrial-fibrillation-100589800",false,"NCT06959121","CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation","Pulse Biosciences' CellFX nsPFA Cardiac Surgery Clamp System for the Treatment of Atrial Fibrillation During Concomitant Cardiac Surgery","NANOCLAMP-AF","Inclusion Criteria:\n\n* Subject must be between 18 and 85 years of age\n* 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\n* Subject has history of documented paroxysmal atrial fibrillation (AF that is intermittent and terminates within ≤ 7 days of onset) or persistent\u002Flongstanding 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\n* 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)\u002FPatent Foramen Ovale (PFO) or Coronary artery bypass procedures\n* Left ventricular ejection fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)\n* Subject has a life expectancy of at least 5 years\n* Subject currently lives within a reasonable commuting distance of the investigational site and plans to remain geographically stable through 12 month follow up\n\nExclusion Criteria:\n\n* 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\n* Subject has history or known to have LAA clot\n* Subject has a prosthetic heart valve\n* Stand- alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and\u002For valve surgery\n* Prior cardiac surgery including prior cardiac surgical ablation\n* Left Atrial diameter ≥ 6cm\n* Wolff-Parkinson-White syndrome or other Supra-Ventricular Arrhythmia, Atrioventricular (AV) nodal reentry\n* Documented history of persistent or long standing persistent atrial fibrillation longer than 10 years\n* Subjects requiring surgery other than CABG and\u002For cardiac valve surgery and\u002For atrial septal defect repair\u002FPFO and ascending aorta\n* Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)\n* Subjects that are on an AAD for ventricular arrhythmia.\n* STS Predicted Risk of Mortality (STS PROM) of 10 or higher\n* Class III or IV New York Heart Association (NYHA) heart failure symptoms\n* Prior history of stroke within 6 months\n* Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment\n* Need for emergent cardiac surgery (per sit-to-stand (STS) test definition)\n* Known carotid artery stenosis greater than 80%\n* Current diagnosis of active systemic infection\n* Severe peripheral arterial occlusive disease defined as claudication with minimal exertion\n* 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)\n* A known drug and\u002For alcohol addiction\n* Mental impairment or other conditions that may not allow the subject to understand the nature, significance, and scope of the study\n* Pregnancy or desire to get pregnant within 12 months of the study treatment\n* Preoperative need for an intra-aortic balloon pump or intravenous inotropes\n* Subjects who have been treated with thoracic radiation\n* Subjects in current chemotherapy\n* Subjects on long-term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)\n* Subjects with known hypertrophic obstructive cardiomyopathy\n* Subjects with known cold agglutinin\n* Subject has a contraindication to anticoagulation (e.g., a bleeding or clotting disorder such as Idiopathic Thrombocytopenic Purpura (ITP))\n* Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n* Body mass index \\> 45 kg\u002Fm2\n* Any diagnosed connective tissue disorder\n* Severe Chronic Obstructive Pulmonary Disease (COPD) per sit-to-stand (STS) test definition\n* Use of any other investigational drug, therapy, or device within 30 days before enrollment or concurrent participation in another research study","ALL","18 Years","85 Years",{"count":21,"type":22},135,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31],"Atrial Fibrillation","Maze Procedure","AF","Ablation",[33],"nsPFA","RECRUITING","2026-01-09",{"date":37,"type":38},"2026-01-12","ACTUAL",{"date":40,"type":38},"2025-10-23",{"date":42,"type":22},"2028-12",{"name":44,"class":45},"Pulse Biosciences, Inc.","INDUSTRY",2,""]