[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-ablation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-ablation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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]