[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550958":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":69,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":11,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"MicroPort CRM","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"FLEXIGO delivery catheter","EXPERIMENTAL",null,[13],"Device: Use of FLEXIGO delivery catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Use of FLEXIGO delivery catheter","Use of FLEXIGO delivery catheter for implantation of ventricular pacing lead",[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",[27,43,57],{"facility":28,"status":29,"city":30,"state":11,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"ULS de Coimbra","RECRUITING","Coimbra","Portugal","PT",{"type":34,"coordinates":35},"Point",[36,37],-8.41996,40.20686,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":11,"phoneExt":11,"email":42},"João Ferreira","joaoaferreira29@gmail.com",{"facility":44,"status":29,"city":45,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Hospital Universitario Virgen de las Nieves","Granada","Spain","ES",{"type":34,"coordinates":49},[50,51],-3.60667,37.18817,{"lat":51,"lon":50},[54],{"name":55,"role":23,"phone":11,"phoneExt":11,"email":56},"Manuel Molina","manuel.molina.lerma@gmail.com",{"facility":58,"status":29,"city":59,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Hospital Universitari i Politècnic La Fe","Valencia",{"type":34,"coordinates":61},[62,63],-0.37966,39.47391,{"lat":63,"lon":62},[66],{"name":67,"role":23,"phone":11,"phoneExt":11,"email":68},"Óscar Cano","oscape13@hotmail.com",{"type":70,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100550958","safety-and-performance-evaluation-of-a-new-catheter-range-for-lead-implantation-at-interventricular-septum-100550958",false,"NCT06453850","Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum","POLARIS","Inclusion criteria (phase I):\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 any Single Chamber (SR) or Dual Chamber (DR) CE marked pacemaker\n* Patient planned for a catheter-guided implantation in the interventricular septum area\n* Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter\n* Patient reviewed, signed and dated the Informed Consent Form (ICF)\n\nInclusion criteria (phase II):\n\n* Patient indicated for cardiac pacing or CRT according to the most recent guidelines from the ESC\n* Patient planned for a de novo implantation of any SR or DR CE marked pacemaker, or any CE marked CRT-D\n* Patient planned for a catheter-guided implantation in the interventricular septum area\n* Patient planned for the implantation of any CE marked ventricular pacing lead compatible with the FLEXIGO delivery catheter\n* Patient reviewed, signed and dated the ICF\n\nExclusion criteria (phase I):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease\n* Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic 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 implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, 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* 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\n\nExclusion criteria (phase II):\n\n* Patient planned for a device upgrade, or a device or a lead replacement\n* Patient with a congenital heart disease\n* Patient with significant hypertrophic cardiomyopathy, cardiac amyloidosis or obstructive hypertrophic cardiomyopathy\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 implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, 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* 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":81,"type":82},216,"ESTIMATED","INTERVENTIONAL",[85],"NA","The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.",[88,89,90],"Bradycardia","Cardiac Resynchronization Therapy","Left Bundle Branch Area Pacing","2025-03-03",{"date":93,"type":94},"2025-03-06","ACTUAL",{"date":96,"type":94},"2025-02-14",{"date":98,"type":82},"2026-12",{"name":5,"class":6},3]