[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pulse Biosciences, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":148},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,71,98,124],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100594373","ns-pfa-catheter-ablation-of-paroxysmal-atrial-fibrillation-with-the-pulse-biosciences-cellfx-system-100594373",false,"NCT07018596","NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System","Safety and Effectiveness of the CellFX® nsPFA Catheter Endocardial Ablation System for the Treatment of Paroxysmal Atrial Fibrillation","NANOPULSE-AF","Inclusion Criteria:\n\n* A diagnosis of recurrent drug-resistant symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within seven (7) days of onset, documented by the following:\n\n  i. Physician's note indicating the presence of AF symptoms and at least two (2) episodes of self-terminating AF within six (6) months prior to enrollment\n* Age 18 through 85 years old (or older than 18 if required by local law)\n* Failure of at least one AAD (class I or III) for AF as evidenced by recurrence of symptomatic AF, or intolerable side effects due to AAD.\n* Participant is willing and capable of providing Informed Consent\n* Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by study investigators\n\nExclusion Criteria:\n\n* Left atrial diameter ≥5.5 cm (anteroposterior)\n* Any of the following within 3 months prior to enrollment:\n\n  1. Any cardiac surgery\n  2. Myocardial infarction\n  3. Percutaneous Coronary Intervention (PCI) \u002F Percutaneous Coronary Intervention (PTCA) or coronary artery stenting\n  4. Unstable angina\n  5. Pericarditis or symptomatic pericardial effusion\n* Any of the following within 6 months prior to enrollment:\n\n  1. Any cerebral ischemic event (stroke or transient ischemic attack (TIA)\n  2. History of thromboembolic event\n* Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, Left atrial appendage occlusion)\n* Planned Left Atrial Appendage (LAA) closure procedure, Transcatheter Aortic Valve Replacement (TAVR), Mitraclip, Atrial Septal Defect (ASD) or Patent Foramen Ovale (PFO) closure, Triclip or implant of an Implantable Loop Recorder (ILR), permanent pacemaker, biventricular pacemaker, or any implantable cardiac defibrillator (with or without biventricular pacing function) during or for any time during the follow-up period\n* Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure\n* Documented left atrial (LA) thrombus by imaging within 48 hours of the procedure.\n* Presence of a permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator (with or without biventricular pacing function).\n* Prior diagnosis of pulmonary vein stenosis\n* Valvular cardiac surgical\u002Fpercutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).\n* Moderate to severe mitral valve stenosis\n* More than moderate mitral regurgitation (i.e., 3+ or 4+ MR)\n* New York Heart Association (NYHA) Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measured by acceptable cardiac testing (e.g., TTE)\n* History of pulmonary hypertension with pulmonary systolic artery pressure \\>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease\n* Rheumatic heart disease\n* Contraindication to anticoagulation (i.e., Heparin, Dabigatran, Apixaban, Vitamin K Antagonists such as warfarin)\n* Active systemic infection\n* Hypertrophic or advanced infiltrative cardiomyopathy\n* Atrial myxoma\n* Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity\n* History of abnormal bleeding and\u002For clotting disorder\n* Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2, or any history of renal dialysis or renal transplant\n* History of severe chronic gastrointestinal problems involving the esophagus, stomach and\u002For untreated acid reflux\n* Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n* Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\n* Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and\u002For alcohol addiction, congenital disease, fragility)\n* Body Mass Index (BMI) \\> 40.0\n* Participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)\n* Life expectancy less than one year\n* Current or anticipated participation in any other clinical study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor\n* Unwilling or unable to comply fully with study procedures and follow-up","ALL","18 Years","85 Years",{"count":21,"type":22},215,"ESTIMATED","INTERVENTIONAL",[25],"NA","The objective of this study is to demonstrate the safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA) Cardiac Catheter Ablation System in treating recurrent, drug-resistant, symptomatic paroxysmal atrial fibrillation (AF).",[28,29,30],"Atrial Fibrillation Paroxysmal","Cardiac Ablation","Cardiac Arrhythmia",[32,33,34],"nsPFA","Pulsed Field Ablation","nano-PFA","RECRUITING","2026-05-03",{"date":38,"type":39},"2026-05-06","ACTUAL",{"date":41,"type":39},"2026-04-06",{"date":43,"type":22},"2028-01",{"name":45,"class":46},"Pulse Biosciences, Inc.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100569586","cellfx-nanosecond-pulsed-field-ablation-pfa-360-catheter-ablation-system-for-treatment-of-atrial-fibrillation-100569586","NCT06696170","CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation","Initial Safety and Performance of the CellFX® Nano-PFA 360 Catheter Endocardial Ablation System for the Treatment of Atrial Fibrillation","Inclusion Criteria:\n\n* Subject must be ≥ 18 and ≤ 75 years of age on the day of enrollment\n* Subject is willing and capable of providing Informed Consent to undergo study procedures and participate in all examinations and follow-up visits and tests associated with this clinical study\n* Subjects with PAF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip\n* Subjects who have failed at least one antiarrhythmic drug (AAD; class I or III, or AV nodal blocking agents such as beta blockers and calcium channel blockers) as shown by recurrent symptomatic AF, or intolerance to the AAD or AV nodal blocking agents\n* Antero-posterior left atrial diameter ≤ 5.5 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 3 months prior to the procedure\n* Left ventricular ejection fraction ≥ 40% as documented by TTE within 12 months prior to the procedure\n* Received a standard cardiac work up and is an appropriate candidate for an investigational procedure as determined by the study investigators\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* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause\n* AF episodes lasting \\> 7 days\n* Previous ablation for AF\n* Subjects on amiodarone at any time during the past 3 months prior to enrollment\n* Prior history of pericarditis or pericarditis within 3 months based on the TTE examination\n* Prior history of rheumatic fever\n* Prior history of medical procedure involving instrumentation of the left atrium (previous ablation, atrial septal defect (ASD) closure, left atrial appendage occlusion)\n* History of severe chronic gastrointestinal problems involving the esophagus, stomach and\u002For untreated acid reflux\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* Active malignancy or history of treated cancer within 24 months of enrollment\n* Clinically significant infection or sepsis on the day of index procedure with either fever, leukocytosis or requiring intravenous antibiotics\n* History of stroke or TIA within prior 6 months, or any prior intracranial hemorrhage or permanent neurological deficit\n* New York Heart Association (NYHA) class IIIb or IV congestive heart failure and\u002For any heart failure hospitalization within 3 months prior to enrollment\n* Body mass index \\> 35 kg\u002Fm2\n* Estimate glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2 or has ever received hemodialysis\n* History of untreated and serious hypotension, bradycardia or chronotropic incompetence\n* Any of the following within 3 months of enrollment:\n\n  1. Major surgery except for the index procedure\n  2. Myocardial infarction\n  3. Unstable angina\n  4. Percutaneous coronary intervention\n  5. Sudden cardiac death event\n  6. Left atrial thrombus that has not resolved as shown by TEE or CT\n* Solid organ or hematologic transplant, or currently being evaluated for an organ transplant\n* History of pulmonary hypertension with pulmonary systolic artery pressure \\>50 mm Hg, severe Chronic Obstructive Pulmonary Disease or restrictive lung disease\n* Subjects with any other significant uncontrolled or unstable medical condition (such as uncontrolled brady-arrhythmias, ventricular arrhythmias, hyperthyroidism or significant coagulation disorder)\n* Life expectancy less than one year\n* Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.\n* Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period\n* Other criteria, which the Investigator determines would make the patient unsuitable to participate (e.g. uncontrolled drug and\u002For alcohol addiction, congenital disease, fragility)","75 Years",{"count":57,"type":22},60,[25],"The objective of this study is to demonstrate initial safety and effectiveness of the CellFX nano-second Pulsed Field Ablation (nsPFA or nano-PFA) 360 Catheter Endocardial Ablation System in treating subjects with atrial fibrillation.",[28,29,30],[32,62,33,34],"CellFX",{"date":64,"type":39},"2026-05-05",{"date":66,"type":39},"2024-07-25",{"date":68,"type":22},"2026-07-25",{"name":45,"class":46},3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":70},"100615021","prospective-evaluation-of-the-pulse-biosciences-npulse-vybrance-percutaneous-electrode-system-100615021","NCT07287176","Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System","Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN) Study","PRECISE-BTN","Inclusion Criteria:\n\n* Participant is willing and able to provide voluntary, written informed consent to participate in this study and from whom written informed consent has been obtained\n* Participants must be willing and able to comply with study procedures including all follow-up visits\n* Selected nodule is amenable to trans-isthmus approach\n* Nodule is confirmed as benign based on results from one or more of the following diagnostic tests:\n\n  1. (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);\n  2. A single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features \\[American College of Radiology (ACR) Thyroid Imaging Reporting \\& Data System \\[TI-RAD\\] TR 1-3, American Thyroid Association \\[ATA\\] very low suspicion\\];\n  3. Candidate has a hyperfunctional nodule following 1 ultrasound guided FNA or CNB with or without molecular testing; or\n  4. Benign (Bethesda III or IV) with two biopsies in addition to molecular testing confirming benign diagnosis\n* Selected nodule is \\\u003C80.0 ml\n* Participant has normal vocal cord mobility by ultrasound evaluation\n* Participant has presence of compression symptoms, cosmetic concerns or anxiety for which participant requests treatment of the benign thyroid nodule\n* Participant has a solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter\n\nExclusion Criteria:\n\n* Participant has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter defibrillator)\n* Participant has cystic nodules (\\\u003C 70% solid components)\n* Participant has calcified nodules\n* Participant is known to be immune compromised\n* Participant had previous neck irradiation\n* Participant has abnormal cervical lymph nodes present during screening visit examination\n* Participant has history of familial thyroid cancer in more than two first-degree relatives\n* Selected nodule previously treated with radiofrequency ablation or ethanol. This does not apply to nodules previously treated with nanosecond Pulsed Field Ablation (nsPFA)\n* Participants currently suffering from a hematological disease or bleeding tendency\n* Selected nodule likely to be in contact with the recurrent laryngeal nerve on ultrasound evaluation\n* Participant has a history of uncontrolled cardiac arrhythmia, uncontrolled hypertension, chronic liver disease or chronic kidney disease (Stage 4-5), or recent history of myocardial infarction or structural heart disease as determined by the Investigator\n* Participant has abnormal contralateral vocal cord function\n* Anesthesia drug allergies\n* Participant is pregnant at the time of screening or within 30 days prior to enrollment\n* Participant has any condition or situation which, in the Investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study\n* Use of any investigational device or drug within 30 days prior to enrollment that may confound the results of this study","22 Years","80 Years",{"count":82,"type":22},100,[25],"The primary objective of this study is to reproduce in a multi-center study results obtained during the feasibility First-In-Human (FIH) study with Prof. Stefano Spiezia, MD (Ospedale del Mare, Naples, Italy) and to monitor additional thyroid-related symptoms and impact of patients quality of life post-ablation using a validated QoL questionnaire.",[86,87,88],"Thyroid Nodule","Thyroid Goiter","Ablation",[32,33],"2026-04-13",{"date":92,"type":39},"2026-04-15",{"date":94,"type":39},"2025-08-21",{"date":96,"type":22},"2027-06-30",{"name":45,"class":46},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100589800","cellfx-nanosecond-pulsed-field-ablation-nspfa-cardiac-surgery-clamp-system-to-treat-atrial-fibrillation-100589800","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",{"count":107,"type":22},135,[25],"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.",[111,112,113,88],"Atrial Fibrillation","Maze Procedure","AF",[32],"2026-01-09",{"date":117,"type":39},"2026-01-12",{"date":119,"type":39},"2025-10-23",{"date":121,"type":22},"2028-12",{"name":45,"class":46},2,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},"100543376","cellfx-nspfa-cardiac-surgery-system-to-treat-atrial-fibrillation-100543376","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",{"count":132,"type":22},30,[25],"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.",[111,136,137,138],"Surgery","Ablation of Atrial Fibrillation","Clamp Study",[62,140],"nsPFA Cardiac Surgery System",{"date":117,"type":39},{"date":143,"type":39},"2024-07-31",{"date":145,"type":22},"2027-12-31",{"name":45,"class":46},6,""]