[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-fibrillation-postoperative\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-fibrillation-postoperative":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100592157","boxx-noaf-clinical-trial-100592157",false,"NCT06989775","BoxX-NoAF Clinical Trial","EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation","Inclusion Criteria:\n\n* Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium\n* Age ≥ 65 years and CHA2DS2-VASc ≥ 3\n\nExclusion Criteria:\n\n* Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery\n* Prior procedure involving opening the pericardium or entering the pericardial space\n* Patients undergoing off-pump surgery\n* Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)\n* Presence of a permanent pacemaker\n* Infiltrative cardiomyopathies (i.e. amyloidosis)\n* Planned cardiac surgical procedure using non-sternotomy approaches\n* Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices\n* Presence of ventricular arrhythmia\n* Active endocarditis\n* NYHA Class IV heart failure symptoms\n* Preoperative need for an intra-aortic ballon pump or intravenous inotropes\n* Active systemic infection at the time of cardiac surgery requiring antibiotics\n* Known allergy to Nitinol or nickel sensitivity\n* Known medical condition with expected survival of less than 1 year\n* Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits\n* Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial\n* Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.\n* Pregnancy\n* Known severe symptomatic carotid disease",true,"ALL","65 Years",{"count":20,"type":21},960,"ESTIMATED","INTERVENTIONAL",[24],"NA","Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.",[27,28],"Post Operative Atrial Fibrillation","Atrial Fibrillation, Postoperative",[30,31],"Post operative AF","Clinical AF","RECRUITING","2026-06-26",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2025-10-24",{"date":40,"type":21},"2029-12",{"name":42,"class":43},"AtriCure, Inc.","INDUSTRY",27,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100572250","phase-1-amiodarone-infused-cardiamend-patches-for-the-prevention-of-new-onset-poaf-in-cardiac-surgery-subjects-100572250","NCT06730828","Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects","Use of Amiodarone-Infused CardiaMend (CardiaMend-Amiodarone) Patches for the Prevention of New-Onset Postoperative Atrial Fibrillation (POAF) in Subjects Undergoing Cardiac Surgery","AMIOMEND","Inclusion Criteria:\n\n* Subjects 20-85 years old.\n* Subjects able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.\n* Subjects scheduled to undergo open-chest cardiac surgery via complete median sternotomy.\n* Subjects in sinus rhythm at the time of office visit and during prior EKG (note: continuous EKG monitoring for 48 hours is not required).\n\nExclusion Criteria:\n\n* Subjects unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including subjects institutionalized by court or official order, or in a dependency relationship with testing center or investigator.\n* Subjects with a condition that could interfere with their ability to comply with the study.\n* Subjects participating in an interventional clinical study or who have participated in such study during the preceding 30 days.\n* Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the study.\n* Subjects with active skin or deep infection at the site of implantation.\n* Subjects with a history of chronic wounds or wound-healing disorders.\n* Subjects with known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).\n* Subjects who are Immune-suppressed or with immune deficiency (properly managed diabetes mellitus is not an exclusion criterion).\n* Subjects on concomitant oral or IV systemic corticosteroid therapy and\u002For other constant anti-inflammatory therapies.\n* Subjects on the following medications with known interactions with amiodarone: doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir\u002Fsofosbuvir, quinidine , procainamide, disopyramide, other Vaughan William class III agents including dofetilide, dronedarone, ibutilide and vernakalant.\n* Subjects with coadministration of any medications which cause QT prolongation\n* Subjects with implantable cardiac devices (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD), and pacemakers).\n* Subjects with a known history of atrial fibrillation or paroxysmal atrial fibrillation.\n* Subjects with a history of ablation for atrial fibrillation.\n* Subjects already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.\n* Subjects with a disease of the left pleura, previous intervention in the left pleural space, or chest deformity.\n* Subjects with heart failure (BNP\\>1000), low ejection fraction (\\\u003C35%), end-stage renal disease (on dialysis or GFR\\\u003C20).\n* Subjects electing to receive an ablative procedure for atrial fibrillation during the index operation.\n* Subjects with prior cardiac surgery via sternotomy.","20 Years","85 Years",{"count":56,"type":21},80,[58,59],"PHASE1","PHASE2","The goal of this clinical trial is to is to test the safety of a new way to deliver a commonly used drug (amiodarone) used in heart surgery by placing a patch containing the drug directly on the heart instead of in an IV (vein). Participating subjects must be 20-85 year old males or females. Up to 80 participants having cardiac surgery at the University of Louisville will be involved in this study.\n\nThe main questions this study aims to answer are:\n\n1. Is the patch safe?\n2. Does the patch lower the rate of atrial fibrillation (irregular heart rhythm) after cardiac surgery?\n\nResearchers will compare up to 3 different doses of the amiodarone patches (low, medium and high) to the usual treatment (Standard of Care) to see if there are differences (increases or decreases) in heart rhythms after cardiac surgery across study groups.\n\nParticipants will be placed in one of 4 study groups:\n\n* Standard of Care (20 participants)\n* Low dose patch (20 participants)\n* Medium dose patch (20 participants)\n* High dose patch (20 participants)\n\nParticipants will be monitored closely by their doctor(s) during the study and would:\n\n* Agree to participate after having their doctor, or a member of the team, explain the study in detail and allowing them to ask any questions they would like.\n* Sign an Informed Consent Form which will describe the study and tests in full.\n* Agree to have their doctor and his\u002Fher research team record your medical information, draw blood, and perform electrocardiograms, or EKGs (quick, painless test that measures the electrical activity of the heart) and echocardiograms (image of heart) to monitor their heart.\n* Agree to receive training on the portable EKG recorder and to use it at home approximately 30 days and 6 months after their surgery to monitor their heart.\n* Agree to return to the hospital approximately 30 days and 6 months after their surgery for a study visit.\n\nParticipant involvement will be approximately 7 months total.",[28],[63,64,65,66,67,68],"post Operative Atrial Fibrillation","Arrhythmias","Cardiac Heart Diseases","Cardiovascular Diseases","Atrial Fibrillation","Anti-Arrhythmia Agents","2024-12-11",{"date":71,"type":36},"2024-12-12",{"date":73,"type":21},"2024-12-16",{"date":75,"type":21},"2026-05",{"name":77,"class":43},"Helios Cardio Inc.",1]