[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-implantable-electronic-device\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-implantable-electronic-device":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100637597","stepwise-vs-standard-anticoagulation-for-af-patients-undergoing-cied-implantation-step-af-100637597",false,"NCT07616414","Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)","Stepwise Versus Standard Antithrombotic Strategies in Patients With Atrial Fibrillation at High Thromboembolic Risk Undergoing CIED Procedures (STEP-AF Trial)","STEP-AF","Inclusion Criteria:\n\n1. Aged 18 years or older at the time of screening, and able to provide written informed consent;\n2. Scheduled for any CIED procedure (implantation or generator replacement), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices;\n3. Receiving NOAC therapy for at least 5 consecutive days prior to enrollment;\n4. Diagnosed with non-valvular atrial fibrillation (and\u002For atrial flutter) with a CHA₂DS₂-VASc score ≥2, or scheduled for cardioversion or defibrillation threshold testing during the CIED procedure.\n\nExclusion Criteria:\n\n1. Presence of active systemic or local infection at the time of screening;\n2. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin, or any other contraindication to NOAC use;\n3. Active bleeding (e.g., gastrointestinal bleeding);\n4. Severe thrombocytopenia, defined as platelet count \\\u003C 50 × 10⁹\u002FL at screening;\n5. Life expectancy \\\u003C1 year;\n6. Pregnancy.","ALL","18 Years",{"count":20,"type":21},424,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a multi-center, prospective, open-label, randomized controlled trial (STEP-AF) designed to evaluate the safety of a stepwise anticoagulation strategy compared with the guideline-recommended standard anticoagulation regimen in patients with non-valvular atrial fibrillation at high thromboembolic risk (CHA₂DS₂-VASc score ≥2) undergoing cardiac implantable electronic device (CIED) implantation. A total of 424 eligible patients will be randomized 1:1 to either the stepwise anticoagulation group (reduced-dose NOAC from 24 hours post-surgery to day 7, followed by standard-dose NOAC) or the standard anticoagulation group (standard-dose NOAC resumed 24 hours post-surgery). The primary endpoint is the incidence of clinically significant pocket hematoma within 30 days after surgery. Secondary endpoints include individual components of the primary endpoint and other composite outcomes of major perioperative bleeding events. The study aims to provide evidence-based data for optimizing perioperative anticoagulation regimens in Chinese patients undergoing CIED implantation.",[27,28,29,30,31],"Non-valvular Atrial Fibrillation (NVAF)","Thromboembolism","Cardiac Implantable Electronic Device","Perioperative Bleeding","Hematoma Postoperative",[33,29,34,35,36,37,38,39,28,30,40,41,42],"Non-valvular atrial fibrillation","CIED","Perioperative Anticoagulation","Non-Vitamin K Antagonist Oral Anticoagulant","NOAC","Stepwise Anticoagulation","Postoperative hematoma","Randomized Controlled Trial","Edoxaban","Rivaroxaban","NOT_YET_RECRUITING","2026-05-23",{"date":46,"type":47},"2026-06-01","ACTUAL",{"date":49,"type":21},"2026-05-26",{"date":51,"type":21},"2026-12-31",{"name":53,"class":54},"Fu Wai Hospital, Beijing, China","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100601034","virtual-reality-in-electrophysiological-procedures-and-device-implantation-the-vr-inep-trial-100601034","NCT07105241","Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial","VR inEP","Inclusion Criteria:\n\n* ≥16 years of age\n* Planned to undergo an invasive electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator).\n* The procedure must be performed under local anesthesia.\n\nExclusion Criteria:\n\n* Patients undergoing procedures using (conscious) sedation\n* Patients who do not speak or understand Dutch\n* History of dementia\n* Severe visual impairment.","16 Years",{"count":65,"type":21},115,[24],"Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands. Although the procedures positively impact health related outcomes on the long term, they are often accompanied by periprocedural pain and anxiety on a shorter term. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative.\n\nIt is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR.\n\nVR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc. Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion. Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation. The primary outcomes are pain perception and anxiety during the procedure as a whole, quantified using the visual analog scale (VAS) for pain and the numeric ranking scale (NRS) for anxiety, 30 minutes after the procedure ends.",[69,29,70,71,72,73],"Arrhythmia","Ablation of Arrhythmias","Electrophysiologic Study","Pacemaker","ICD","2025-07-29",{"date":76,"type":47},"2025-08-05",{"date":78,"type":21},"2025-11-15",{"date":80,"type":21},"2026-07-31",{"name":82,"class":54},"Radboud University Medical Center"]