[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FIAB SpA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100655954","a-prospective-multi-center-single-arm-study-evaluating-the-safety-and-performance-of-the-spike-flow-endocardial-lead-100655954",false,"NCT07820072","SPIKE FLOW Endocardial Lead Safety and Performance Study","A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the SPIKE FLOW Endocardial Lead","SPIKE FLOW","Inclusion Criteria:\n\n* Subject undergoing a surgical or an interventional procedure, requiring temporary cardiac pacing per investigator's medical judgment or subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent;\n* Subject is at least 18 years of age;\n* Subject provides written informed consent to the study.\n\nExclusion Criteria:\n\n* Subject has a co-existing temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator;\n* Subject in cardiogenic shock;\n* Subject is currently in atrial fibrillation;\n* Subject is pregnant or breastfeeding;\n* Subject had a stroke within 6 months prior to enrollment;\n* Subject has renal insufficiency with creatinine \\>2 mg\u002Fdl;\n* Subject with known bleeding diathesis;\n* Subject with a history of deep vein thrombosis or pulmonary embolism within 6 months;\n* Subject with known tricuspid valve disease that may impede catheter advancement to and withdrawal from the right ventricle;\n* Subject with known intracardiac thrombus or vegetation on echocardiography;\n* Subject with significant neck abnormalities such that placement of a right and\u002For left internal jugular vein line would be difficult;\n* Subject has an active systemic infection or local infection at or around the insertion site;\n* Subject is involved in another clinical study that could influence the safety or outcome measures of this study.","ALL","18 Years",{"count":20,"type":21},131,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead.\n\nPrimary objectives are to assess:\n\n* safety in terms of freedom from Serious Adverse Events(SADEs);\n* performance in terms of Mean Pacing Capture Threshold.\n\nSecondary objectives are to assess:\n\n* safety in terms of freedom from Adverse Events (ADEs);\n* performance in terms of Mean Pacing Impedance;\n* performance in terms of Sensed R-wave Amplitude. The study is a prospective, non-randomized, single-arm, multi-center investigation in 131 adult subjects with 3 investigational sites in Italy.\n\nThe study is expected to take approximately 1 year to enroll. Enrolled subjects will have visit timepoints at: baseline, lead insertion, lead removal, discharge and 30 days post lead removal.",[27,28,29,30,31],"Acute Myocardial Infarction (AMI)","Asystole","Bradycardia","AV Block","Ventricular Tachyarrhythmia",[33,34,35,36,37,38,39,40],"acute myocardial infaction","asystole","bradycardia","AV block","Ventricular tachyarrhytmias","Overdrive suppression of tachyarrhytmias","High frequency pacing during percutaneous procedures","Cardiac surgery requiring backup pacing, surveillance of cardiac activity","RECRUITING","2026-09-15",{"date":44,"type":45},"2026-09-18","ACTUAL",{"date":47,"type":45},"2026-08-07",{"date":49,"type":21},"2027-08",{"name":51,"class":52},"FIAB SpA","INDUSTRY",3,""]