[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Klinikum-Fuerth\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,79],{"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":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100414564","zero-fluoroscopy-voltage-guided-vs-linear-cti-ablation-100414564",false,"NCT04678258","Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation","A Zero Fluoroscopy Maximum Voltage Guided Stepwise Approach Using IntellaMiFi Technology Compared to Linear Ablation of the Cavotricuspid Isthmus for Typical Atrial Flutter: the ZERO MAGIC Trial","ZERO MAGIC","Inclusion Criteria:\n\n* Typical (CTI dependent) atrial flutter documented in a standard 12 lead surface ECG\n* Given class I indication for curative CTI ablation according to the current guidelines\n* Over 18 years old\n* Given informed consent\n\nExclusion Criteria:\n\n* Any contraindication for CTI ablation\n* Previous CTI ablation\n* BCB as procedural endpoint not assessable\n* CTI ablation conducted in association with further ablation procedures\n* Patients with CIED (e.g. pacemaker, ICD)\n* Tricuspid valve replacement\n* Right atrial thrombus\n* Pregnant or breastfeeding women\n* Abuse of drugs or alcohol\n* Age \\\u003C 18 years\n* Incompliance to the treatment, e.g. necessary anticoagulation\n* Expected survival less than one year\n* Inability to understand the nature and rationale of the study\n* Inability to take part in the follow up","ALL","18 Years",{"count":20,"type":21},106,"ESTIMATED","INTERVENTIONAL",[24],"NA","Catheter ablation of the cavo-tricuspid isthmus (CTI) is the curative first-line therapy for typical atrial flutter. Currently, two approaches are used in clinical practice. In contrast to the conventional linear ablation approach, the Maximum voltage-guided (MVG) strategy aims to limit ablation to high voltage areas (HVAs) representing the detectable correlate of relevant conducting bundles. Data from registries show that the MVG technique is sufficient to reach comparable clinical outcome with significantly shorter ablation duration when compared to the conventional linear strategy.\n\nDespite growing evidence, however, data from properly powered prospective randomized trials are lacking and the linear approach still remains standard. In addition, data on radiation exposure are controversial.\n\nAs a substrate-based approach, the MVG strategy requires detailed mapping and signal analysis for identification of the individual architecture and exactly targeted energy application. However, the spatial mapping resolution of large tip catheters is limited. The use of the MicroFidelity catheter technology (IntellaMiFi) with high resolution mini-electrodes at the 8 mm catheter tip can be expected to further improve the feasibility of a voltage-guided approach. In addition, the MVG approach theoretically may encompass an increased risk for clinically inapparent reconduction. A prospective study with predefined invasive re-evaluation of persistent CTI block is needed to further evaluate this issue.\n\nObjective of this prospective randomized study is evaluate the performance of the micro-sensor technology for zero-fluoroscopy voltage-guided ablation of typical atrial flutter (AFL) compared with a population undergoing conventional linear ablation including a predefined invasive re-evaluation of persistent CTI block in addition to clinical follow-up.\n\nThe study has been approved by the responsible ethics committee.",[27,28,29],"Catheter Ablation","Atrial Flutter Typical","Radiation Exposure",[31,32,33],"atrial flutter typical","catheter ablation","electroanatomic mapping","RECRUITING","2026-06-12",{"date":37,"type":38},"2026-06-15","ACTUAL",{"date":40,"type":38},"2020-11-30",{"date":42,"type":21},"2027-08-31",{"name":44,"class":45},"Klinikum-Fuerth","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":46},"100394507","pacing-to-maintain-physiologic-ventricular-activation-100394507","NCT04416958","Pacing to Maintain Physiologic Ventricular Activation","Pacing for Cardiac Resynchronisation Using the Intrinsic Conduction System to Maintain Physiologic Ventricular Activation","Pace-Conduct","Inclusion Criteria:\n\n* Pacemaker or ICD Implantation aiming to avoid pacing induced ventricular dyssynchrony according to current guidelines\n* age \\>= 18 years\n\nExclusion Criteria:\n\n* no informed consent for the procedure given\n* no follow-up data",{"count":56,"type":21},200,"1 Year","OBSERVATIONAL","Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest guidelines. However, compared to conventional device implantation, cardiac resynchronization, His bundle pacing and left bundle area pacing remain demanding procedures in the individual case. Goal of the single center observational \"Pace conduct\" study is to evaluate implantation success, safety and outcome of pacing methods that maintain physiologic ventricular activation.",[61,62,63,64,65,66],"Pacemaker DDD","His Bundle Pacing","LBB Area Pacing","Pacing-Induced Cardiomyopathy","Left Bundle-Branch Block","ICD",[68,69,70],"His bundle pacing","LBB area pacing","cardiac resynchronisation therapy","2024-10-11",{"date":73,"type":38},"2024-10-15",{"date":75,"type":38},"2018-01-01",{"date":77,"type":21},"2030-12-31",{"name":44,"class":45},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":89,"studyType":58,"phases":4,"briefSummary":90,"conditions":91,"keywords":97,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":105,"locationsCount":106},"100387938","perioperative-management-evaluation-in-patients-with-cied-100387938","NCT04331249","Perioperative Management Evaluation in Patients With CIED","Perioperative Management Evaluation in Patients With Implanted Cardiac Electronic Devices","EVINCE","Inclusion Criteria:\n\n* implanted CIED (e.g. pacemaker, ICD, CRT),\n* performed (non-CIED related) surgical or catheter-based procedure,\n* data from peri-procedural CIED interrogation available\n* age \\>18 years\n\nExclusion Criteria:\n\n* no implanted CIED,\n* no data from any peri-interventional CIED interrogation available",{"count":88,"type":21},500,"1 Month","Background: Recommendations for peri-operative management in patients with implanted cardiac electronic devices (CIED) are often based on older data from case reports and small collectives.\n\nObjective: To evaluate the peri-operative management and outcome of patients with implanted CIED undergoing non-CIED related surgery or catheter-interventional procedures in clinical routine.\n\nStudy design: bi-center, non-randomized, observational registry, retrospective data-collection, on-going prospective patient enrollment, descriptive statistics\n\nPrimary endpoint: number and type of peri-operative adverse device related events (ADE) Secondary endpoints: pre-interventional data (patient characteristics, data from CIED interrogation); peri-interventional data (type of surgery\u002Fintervention, anesthesiology techniques, any AE), postinterventional data (data from post-interventional CIED interrogation, need for reprogramming \u002F device revision).\n\nInclusion criteria: implanted CIED, non-CIED related surgical or catheter-based intervention, peri-procedural CIED interrogation, age \\>18 years Exclusion criteria: no implanted CIED, no data from any peri-procedural CIED interrogation available\n\nPatient enrollment: retrospectively beginning from 2008, further on-going prospective inclusion Sample size: For the observational study, there is no pre-specified sample size. Data from more than 500 patients undergoing \\> 700 interventions are expected.",[92,93,94,95,96],"Cardiac Pacemaker Malfunction","ICD Malfunction","Cardiac Pacemaker Electrical Interference","Anesthesia Complication","Surgery--Complications",[98,99,70,100],"pacemaker","implanted cardioverter defibrillator","management, peri-operative",{"date":73,"type":38},{"date":103,"type":38},"2018-11-27",{"date":77,"type":21},{"name":44,"class":45},2,""]