[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiac-rhythm-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiac-rhythm-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,74,104],{"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":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100602042","biotronik-investigation-of-the-liviq-leadless-pacemaker-system-100602042",false,"NCT07118358","BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System","BIO-LivIQ","Inclusion criteria:\n\n1. Class I or Class II indication for ventricular pacing (VVI\u002FVDD) according to applicable guidelines\n2. Age is greater than or equal to 18 years at time of consent\n3. Able to understand the nature of the study and provide written informed consent\n4. Able and willing to complete all study requirements, including completion of all planned in-office study visits, for the expected duration of follow-up\n\nExclusion criteria:\n\n1. AV block with a ventricular escape rhythm ≤ 30 bpm at time of consent Note: Restriction removed after early safety phase objectives are met\n2. Femoral venous anatomy that is unable to accommodate the introducer or the cardiac anatomy does not allow a leadless pacemaker in the right ventricle\n3. Morbid obesity which may prevent the LivIQ device from obtaining telemetry communication within a range of 20 cm, in the physician's judgement\n4. Intolerance of dexamethasone acetate\n5. Other implanted devices that, in the judgement of the implanting physician, could interfere (mechanically or electrically) with the leadless pacemaker or with the implant procedure\n6. Allergy to the materials of the leadless pacemaker or the implant tools that are in contact with the human body\n7. Prior leadless pacemaker implant attempt\n8. Existing transvenous or leadless pacemaker, transvenous or subcutaneous ICD, or CRT device or previous extraction in which transvenous leads (full or partial) were left in the heart Note: Exception given to use temporary transvenous pacemakers\n9. CIED device extraction within the previous 72 hours or signs of active infection after CIED extraction Note: Patients with extraction due to potential systemic infection must have a blood culture. A blood culture is considered negative if there is no growth within 72 hours prior to the LivIQ implant.\n10. Planned ICD or CRT device implant\n11. Unstable angina pectoris or acute myocardial infarction within 30 days prior to enrollment\n12. Life expectancy of less than 12 months\n13. Unable to tolerate an urgent sternotomy\n14. Planned right-sided heart intervention within 30 days after implant Note: Exception given to AV nodal ablations when performed by an implanting investigator once early safety phase objectives are met\n15. Listed for or has received a heart transplantation or has a left ventricular assist device (LVAD)\n16. Participation or plan to participate in any other potentially confounding investigational drug or device trial, or any other clinical trial that may interfere with this study's treatment or protocol during the duration of the study Note: Co-enrollment in concurrent trials is only allowed when documented prior approval is obtained from BIOTRONIK\n17. Unable to attend in-person planned or emergent study site visits (e.g., frequent or extended travel plans)\n18. Pregnant or plan to become pregnant during the duration of the study\n\nAVS Sub-Study Inclusion Criteria:\n\nAfter consenting to the main study, patients potentially eligible for the AVS Sub-Study must meet these additional criteria:\n\n1. Willing and able to perform the requested procedures for the AVS assessments\n2. Current or history of AV block Note: This includes patients with any degree or type of AV block, irrespective of related symptoms and relevance of the AV block for the underlying pacemaker indication\n\nAVS Sub-Study Exclusion Criteria:\n\nAfter consenting to the main study, patients potentially eligible for the AVS Sub-Study must not meet the following criterion:\n\n1\\. Permanent AF","ALL","18 Years",{"count":19,"type":20},325,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this Investigational Device Exemption trial is to confirm the safety and performance of the LivIQ leadless pacemaker system, in patients with a Class I or II indication for ventricular pacing (VVI\u002FVDD) according to applicable guidelines. An integrated atrioventricular synchrony sub-study (AVS) is specifically designed to evaluate the AVS performance of the LivIQ system.",[26,27,28,29],"Leadless Pacemaker","Bradycardia","AV Block","Cardiac Rhythm Disorder",[31],"leadless pacemaker","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":36},"2026-03-16",{"date":40,"type":20},"2028-04",{"name":42,"class":43},"Biotronik, Inc.","INDUSTRY",13,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100499812","incidence-and-morbidity-of-cardiac-rhythm-disorders-in-patients-assisted-by-ecmo-va-for-refractory-cardiogenic-shock-100499812","NCT05788120","Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock","Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock","CAVA-ECMO","Inclusion Criteria:\n\n* Patient 18 years of age or older\n* Assistance with VA ECMO\n\nExclusion Criteria:\n\n* Opposition to the use of data.\n* Persons under legal protection (curators, guardianship), judicially safeguarded.\n* VA ECMO for refractory cardiac arrest.",{"count":54,"type":20},600,"OBSERVATIONAL","Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients.\n\nWhile the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO.\n\nThe primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.",[29],[59,60,61,62],"Arrhythmia","Veno-arterial Extra Corporeal Membrane","Oxygenation (VA ECMO)","Cardiogenic shock.","2026-04-16",{"date":65,"type":36},"2026-04-17",{"date":67,"type":36},"2023-04-28",{"date":69,"type":20},"2028-04-28",{"name":71,"class":72},"Assistance Publique - Hôpitaux de Paris","OTHER",20,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100557796","atrial-anomalies-predict-silent-atrial-fibrillation-detected-by-implantable-cardiac-monitor-in-cryptogenic-stroke-100557796","NCT06542770","Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke","Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial","CRIPTO-FAST","Inclusion Criteria:\n\n* Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023\n* Age between 50 and 89 years;\n* Undetermined origin at hospital admission according to the SSS-TOAST criteria (2):\n\n  1. Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular\u002Frheumatic disease, absence of intracardiac shunts)\n  2. Absence of AF during 48h ECG-monitoring\n  3. Absence of major anomalies in the supra-aortic trunks ultrasound.\n\nExclusion Criteria:\n\n1. Patients with a history of hemorrhagic stroke;\n2. Presence with prior atrial fibrillation or atrial flutter;\n3. Permanent contraindication or indication for OAC for other reasons;\n4. Recent (\\\u003C1 month) major surgery or cardiac events;\n5. Presence of severe cardiac abnormalities;\n6. Patients with life expectancy \\\u003C1 year or severe stroke (modified Rankin Scale \\> 4).","50 Years","89 Years",{"count":85,"type":20},100,[23],"Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF.\n\nThe purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.",[89,29,90,91],"Paroxysmal Atrial Fibrillation","Left Atrial Dilatation","Cryptogenic Stroke",[93],"Atrial strain. Implantable cardiac monitor","2024-08-02",{"date":96,"type":36},"2024-08-07",{"date":98,"type":36},"2021-01-01",{"date":100,"type":20},"2024-12",{"name":102,"class":72},"Parc de Salut Mar",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":114,"studyType":55,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":103},"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":113,"type":20},2500,"5 Years","The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.",[29,117,118],"Heart Failure","Sudden Cardiac Death","2024-01-12",{"date":121,"type":36},"2024-01-17",{"date":123,"type":36},"2023-10-30",{"date":125,"type":20},"2031-06-15",{"name":127,"class":43},"MicroPort CRM"]