[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619283":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":33,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":11,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":11},{"fullName":5,"class":6},"MicroPort CRM","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"LINEA cardiac pacing lead","EXPERIMENTAL",null,[13],"Device: Use of LINEA cardiac pacing lead",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Use of LINEA cardiac pacing lead","Use of LINEA cardiac pacing lead and delivery catheter for implantation of pacemaker",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Antoine Guihard","CONTACT","+33 1 46 01 33 20","antoine.guihard@crm.microport.com",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100619283","safety-and-performances-of-the-linea-cardiac-pacing-lead-optimized-for-the-implantation-in-interventricular-septum-100619283",false,"NCT07342608","Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum","STARLIGHT","Inclusion criteria (phase I and II):\n\n* Patient indicated for cardiac pacing according to the most recent guidelines from the European Society of Cardiology (ESC)\n* Patient planned for a de novo implantation of an ALIZEA, BOREA or CELEA Single Chamber (SR) or Dual Chamber (DR) pacemaker from MicroPort CRM\n* Patient planned for a catheter-guided ventricular pacing lead implantation in the interventricular septum area\n* Patient's pacemaker with the remote monitoring functions accepted by the patient and planned to be activated\n\nExclusion criteria (phase I and II):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease, hypertrophic cardiomyopathy or infiltrative cardiomyopathy\n* Patient with a Left Ventricular Ejection Fraction (LVEF) ≤ 35%\n* Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)\n* Patient having a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient for whom a single dose of steroid eluted by the pacing lead (e.g., dexamethasone sodium phosphate) is contraindicated, patient implanted with a tricuspid replacement heart valve, with prior tricuspid valve intervention or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)\n* Patient with a life expectancy of less than 2 years\n* Minor age patient (i.e. under 18 years of age)\n* Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation\n* Non-menopausal women","ALL","18 Years",{"count":38,"type":39},450,"ESTIMATED","INTERVENTIONAL",[42],"NA","The purpose of the clinical investigation is to evaluate the safety and performances of the new LINEA cardiac pacing lead, intended for placement at the interventricular septum.",[45,46,47],"Bradycardia","Left Bundle Branch Area Pacing","Left Bundle Branch Pacing","NOT_YET_RECRUITING","2026-02-13",{"date":51,"type":52},"2026-02-17","ACTUAL",{"date":54,"type":39},"2026-03-31",{"date":56,"type":39},"2030-04-30",{"name":5,"class":6}]