[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ablation-of-atrial-fibrillation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ablation-of-atrial-fibrillation":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100620611","phase-1-relaxin-therapy-for-atrial-fibrillation-100620611",false,"NCT07359872","Relaxin Therapy for Atrial Fibrillation","Relax-in-AF","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with AF and scheduled for elective catheter ablation for AF\n\nExclusion Criteria:\n\n* Enrollment in another Greater than Minimal Risk Study\n* Pregnant, nursing, or sexually active females not using birth control or having been surgically sterilized\n* Females who plan to become pregnant during the trial period\n* Patients diagnosed with \"permanent\" AF, complete heart block, or a reversible cause of AF (e.g., transient thyrotoxicosis)\n* Patients that require antiarrhythmic medication to started or continued during and after the ablation procedure.\n* Patients unable to tolerate Relaxin therapy or unable or unwilling to provide informed consent","ALL","18 Years",{"count":19,"type":20},208,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from \"paroxysmal\" to \"persistent\" to \"permanent\" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.",[27,28,29,30,31,32,33,34],"Atrial Fibrillation (AF)","Arrhythmia","Oxidative Stress","Stroke","Major Cardiovascular Event","Heart Failure","Catheter Ablation","Ablation of Atrial Fibrillation",[36,37],"randomized controlled crossover trial","Randomized clinical trial","NOT_YET_RECRUITING","2026-01-21",{"date":41,"type":42},"2026-01-22","ACTUAL",{"date":44,"type":20},"2027-01-01",{"date":46,"type":20},"2030-12-31",{"name":48,"class":49},"Deeptankar DeMazumder","FED",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"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","85 Years",{"count":59,"type":20},30,[61],"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.",[64,65,34,66],"Atrial Fibrillation","Surgery","Clamp Study",[68,69],"CellFX","nsPFA Cardiac Surgery System","RECRUITING","2026-01-09",{"date":73,"type":42},"2026-01-12",{"date":75,"type":42},"2024-07-31",{"date":77,"type":20},"2027-12-31",{"name":79,"class":80},"Pulse Biosciences, Inc.","INDUSTRY",6]