[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clamp-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clamp-study":30},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100543376","cellfx-nspfa-cardiac-surgery-system-to-treat-atrial-fibrillation-100543376",false,"NCT06355063","CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation","Initial Safety and Performance of the CellFX® nsPFA™ Cardiac Surgery System for the Treatment of Atrial Fibrillation","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 includes surgical AF ablation and completing follow-up visits as specified in the clinical study protocol\n* 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\n* 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\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\nExclusion Criteria:\n\n* Subject has an implantable electronic medical device. (i.e., pacemaker, ICD or CRT) or left atrial appendage device\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* Previous surgical Maze procedure\n* Prior cardiac surgery (Redo)\n* Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry\n* Subjects requiring surgery other than CABG and\u002For cardiac valve surgery and\u002For atrial septal defect repair.\n* Prior history of medical procedure involving instrumentation of the left atrium (e.g., previous ablation)\n* Class IV New York Heart Association (NYHA) heart failure symptoms\n* Prior history of cerebrovascular accident or TIA within 6 months or at any time if there is residual neurological deficit\n* Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment\n* Need for emergent cardiac surgery (i.e., cardiogenic shock)\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\n* A known drug and\u002For alcohol addiction\n* Mental impairment or other conditions which 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* History of abnormal bleeding and\u002For clotting disorder\n* Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)\n* Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n* Body mass index \\> 40 kg\u002Fm2\n* Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study","ALL","18 Years","85 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30],"Atrial Fibrillation","Surgery","Ablation of Atrial Fibrillation","Clamp Study",[32,33],"CellFX","nsPFA Cardiac Surgery System","RECRUITING","2026-01-09",{"date":37,"type":38},"2026-01-12","ACTUAL",{"date":40,"type":38},"2024-07-31",{"date":42,"type":21},"2027-12-31",{"name":44,"class":45},"Pulse Biosciences, Inc.","INDUSTRY",6]