[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"MicroPort CRM\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":136},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,89,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"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":19,"type":20},450,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28],"Bradycardia","Left Bundle Branch Area Pacing","Left Bundle Branch Pacing","NOT_YET_RECRUITING","2026-02-13",{"date":32,"type":33},"2026-02-17","ACTUAL",{"date":35,"type":20},"2026-03-31",{"date":37,"type":20},"2030-04-30",{"name":39,"class":40},"MicroPort CRM","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":66},"100612471","left-bundle-branch-area-pacing-lbbap-monitoring-assistant-evaluation-of-portable-ecg-solution-100612471","NCT07254013","Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution","LBBOT","Inclusion Criteria:\n\n* Subject with indication for LBBAP using an Electrophysiology ECG monitoring system (EP System) as part of pacemaker or CRT-P or CRT-D implant procedure (de novo implant, device revision or upgrade including LOT-CRT)\n* Subject signed and dated the ICF\n\nExclusion Criteria:\n\n* Incapacitated subject or under guardianship\n* inability to understand the purpose of the study\n* Minor subjects\n* Non menopausal women\n* Patients implanted with other electrically active non cardiac devices.",true,{"count":50,"type":20},55,[23],"To evaluate the capability to monitor LBB success criteria with the use of a Smart ECG system (ECG monitor, 12 leads ECG cable, ECG viewer software ) during a cardiac device implantation involving the placement of a pacing lead in interventricular septum area",[26,27,54,55],"Cardiac Resynchronisation Therapy (CRT)","ECG",[57],"LBBAP ECG MONITORING ASSISTANT","RECRUITING","2025-11-27",{"date":61,"type":33},"2025-12-05",{"date":63,"type":33},"2025-11-14",{"date":35,"type":20},{"name":39,"class":40},4,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100550958","safety-and-performance-evaluation-of-a-new-catheter-range-for-lead-implantation-at-interventricular-septum-100550958","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",{"count":75,"type":20},216,[23],"The purpose of the clinical investigation is to evaluate the safety of the FLEXIGO delivery catheter for transvenous pacing lead implantation.",[26,79,27],"Cardiac Resynchronization Therapy","2025-03-03",{"date":82,"type":33},"2025-03-06",{"date":84,"type":33},"2025-02-14",{"date":86,"type":20},"2026-12",{"name":39,"class":40},3,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100451945","clinical-assessment-of-essential-remote-monitoring-functions-in-pacemakers-100451945","NCT05165095","Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers","CALLIOPE","Inclusion Criteria:\n\n1. Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement)\n2. Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM\n3. Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead\n4. Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by the patient and planned to be activated\n5. Patient reviewed, signed and dated the ICF\n\nExclusion Criteria:\n\n1. Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)\n2. Patient with permanent AF\n3. Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)\n4. 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 or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)\n5. Minor age patient (i.e. under 18 years of age)\n6. Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation\n7. Patient unavailable for the follow-up visits scheduled\n8. Non-menopausal women",{"count":97,"type":20},206,"OBSERVATIONAL","The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.",[26,101],"Remote Monitoring","2024-05-30",{"date":104,"type":33},"2024-05-31",{"date":106,"type":33},"2022-03-25",{"date":108,"type":20},"2027-07",{"name":39,"class":40},19,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":121,"studyType":98,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100492624","post-market-surveillance-of-micorport-crm-cardiac-implantable-electronic-devices-100492624","NCT05694572","Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices","PIANO","Inclusion Criteria:\n\nSubjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:\n\n1. Subject implanted with one of the following MicroPort CRM market-released system:\n\n   * ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead\n   * ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional.\n   * GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional.\n   * GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead.\n   * Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead\n2. Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)\n3. Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system\n4. Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are not eligible to be enrolled in the study:\n\n1. Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention\n2. Life expectancy less than 1 year\n3. Currently enrolled in an active study of MicroPort CRM","90 Years",{"count":120,"type":20},2500,"5 Years","The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.",[124,125,126],"Cardiac Rhythm Disorder","Heart Failure","Sudden Cardiac Death","2024-01-12",{"date":129,"type":33},"2024-01-17",{"date":131,"type":33},"2023-10-30",{"date":133,"type":20},"2031-06-15",{"name":39,"class":40},1,""]