[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589800":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":69,"collaborators":71,"id":74,"slug":20,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":20,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Pulse Biosciences, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CellFX nsPFA Clamp","EXPERIMENTAL","Adult subjects who are eligible to participate will undergo a concomitant cardiac surgical procedure with nsPFA ablation (of left and right pulmonary veins as well as roof and floor lesions to form a box) and treatment of left atrial appendage.",[13],"Device: CellFX® nsPFA™ Cardiac Surgery System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","CellFX® nsPFA™ Cardiac Surgery System","Participants will receive cardiac ablation with the CellFX® nsPFA™ Cardiac Clamp",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Matthew A. Romano, MD","University of Michigan, Cardiac Surgery Clinic | Frankel Cardiovascular Center","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Shweta Kalpa, MD","CONTACT","(800) 543-3695","Shweta.Kalpa@pulsebiosciences.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"William A. Knape","(919) 757-2033","bknape@pulsebiosciences.com",[37,55],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Adventist Heart Institute: Adventist Health St. Helena","RECRUITING","St. Helena","California","94574","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-122.47026,38.50519,{"lat":49,"lon":48},[52],{"name":53,"role":29,"phone":54,"phoneExt":20,"email":20},"Aaron M Kime, MD","707-963-7200",{"facility":56,"status":39,"city":57,"state":58,"zip":59,"country":43,"countryCode":44,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Cardiac Surgery Clinic | Frankel Cardiovascular Center","Ann Arbor","Michigan","48109",{"type":46,"coordinates":61},[62,63],-83.74088,42.27756,{"lat":63,"lon":62},[66],{"name":67,"role":29,"phone":68,"phoneExt":20,"email":20},"Matthew A Romano, MD","888-287-1082",{"type":70,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[72],{"name":73,"class":6},"Avania","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":85,"type":86},135,"ESTIMATED","INTERVENTIONAL",[89],"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.",[92,93,94,95],"Atrial Fibrillation","Maze Procedure","AF","Ablation",[97],"nsPFA","2026-01-09",{"date":100,"type":101},"2026-01-12","ACTUAL",{"date":103,"type":101},"2025-10-23",{"date":105,"type":86},"2028-12",{"name":5,"class":6},2]