[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600186":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":10,"responsibleParty":29,"collaborators":10,"id":31,"slug":10,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":34,"acronym":10,"eligibilityCriteria":35,"healthyVolunteers":32,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":10,"studyType":42,"phases":10,"briefSummary":43,"conditions":44,"keywords":47,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":10},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Derivation",null,"These patients will undergo the research protocol. In these patients, we will attempt to implant a permanent conduction system pacing lead, in lieu of the RV or LV lead. The lead will be implanted by operators who have implanted more than 40 leads to overcome the learning curve.",{"label":13,"type":10,"description":14,"interventionNames":10},"Validation","An optimised work flow will be derived using the information collected from the derivation cohort. Namely, the target areas for FAM and electro-anatomical maps will be determined, and the successful pattern of lead septum interaction on CARTO will be defined.\n\nThe streamlined workflow will then be applied to 25 prospective patients. The success rates, procedure time, fluoroscopy time, capture threshold, number of attempted lead deployments and complication rates will be assessed.",{"label":16,"type":10,"description":17,"interventionNames":10},"Control","The control arm will consist of 25 patients undergoing a conduction system pacemaker using conventional pacing methods, with the same pacing indications as the study arm",[19],{"name":20,"affiliation":21,"role":22},"Zachary Whinnett, BM.BS","Imperial College London, Imperial College Healthcare Trust","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Akriti Naraen, MBChB","CONTACT","+91203-31-31000","a.naraen@imperial.ac.uk",{"type":30,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100600186",false,"NCT07094217","Fluoroless Conduction System Implant","Inclusion Criteria:\n\n1. Patients with a ventricular pacing indication: high grade atrioventricular block and symptomatic trifasicular, bifasicular block or left bundle branch block LBBB for cardiac resynchronisation therapy\n2. Adults willing to take part (ages 18 - 100 years old)\n3. Able to give consent.\n\nExclusion Criteria:\n\n1. Unable to give consent\n2. Children age \\\u003C 18 years and adults \\> 100 years old\n3. Pregnant patients • As per standard of care, female patients of child-bearing age will have a urine pregnancy test prior to their procedure.","ALL","18 Years","100 Years",{"count":40,"type":41},75,"ESTIMATED","OBSERVATIONAL","Conduction system pacing is a new way of stimulating the heart using pacemaker wires. Traditional pacemakers stimulate the heart muscle which causes disordered heart beats: the walls of the heart move at different times. This wears down the heart over time.\n\nConduction system pacemakers stimulate the heart's electrical system directly producing natural heart beats that are much less disordered. These pacemakers can be challenging to insert with different heart shapes, sizes and scars. This can increase procedure times and time exposed to xray as pacemakers are inserted using x-rays to guide where the lead is implanted.\n\nThis study aims to allow conduction system pacemakers to be implanted without the use of normal xray (fluoroscopy).\n\nThe investigators will create an anatomical shell of the heart using special plastic (mapping) catheters that is inserted within the heart from the groin. The investigators will use a special heart scanning (echo) catheter to see how the pacemaker wire is inserted into the heart muscle. The investigators will use MRI to confirm that the information we collect is accurate. Using this information the investigators will create a protocol to implant a lead that does not require xray, using only the mapping catheter.",[45,46],"Pacemaker","Conduction System Pacing",[48,49,50],"fluoroless","conduction system pacing","left bundle area pacing","NOT_YET_RECRUITING","2025-07-28",{"date":54,"type":55},"2025-07-30","ACTUAL",{"date":54,"type":41},{"date":58,"type":41},"2026-07-30",{"name":5,"class":6}]