[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520123":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":48,"responsibleParty":201,"collaborators":26,"id":203,"slug":204,"hasResults":205,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":205,"sex":210,"minAge":211,"maxAge":26,"enrollmentInfo":212,"targetDuration":26,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":222,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Physiological Pacing (Conduction System Pacing or Biventricular Pacing)","EXPERIMENTAL","The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.",[13],"Device: Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)",{"label":15,"type":16,"description":17,"interventionNames":18},"Right Ventricular Pacing","ACTIVE_COMPARATOR","Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)",[19],"Device: Continued RV Pacing (Right Ventricular Pacing)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)","The approach for physiological pacing upgrade will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Continued RV Pacing (Right Ventricular Pacing)","Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).",[15],[32,35,38],{"name":33,"affiliation":5,"role":34},"Daniel Keene, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Nandita Kaza, MRCP","STUDY_DIRECTOR",{"name":39,"affiliation":5,"role":37},"Matthew Shun-Shin, PhD",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Aya Khalil","CONTACT","07749576830","a.khalil@imperial.ac.uk",{"name":36,"role":43,"phone":44,"phoneExt":26,"email":47},"n.kaza@imperial.ac.uk",[49,66,79,93,106,119,129,139,149,162,175,188],{"facility":50,"status":51,"city":52,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Royal Papworth Hospital","RECRUITING","Cambridge","United Kingdom","UK",{"type":56,"coordinates":57},"Point",[58,59],0.11667,52.2,{"lat":59,"lon":58},[62,65],{"name":63,"role":43,"phone":26,"phoneExt":26,"email":64},"Sharad Agarwal","sharad.agarwal@nhs.net",{"name":63,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":67,"status":51,"city":68,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"St. Richard's Hospital - University Hospitals Sussex","Chichester",{"type":56,"coordinates":70},[71,72],-0.78003,50.83673,{"lat":72,"lon":71},[75,78],{"name":76,"role":43,"phone":26,"phoneExt":26,"email":77},"Mark Tanner","marktanner@nhs.net",{"name":76,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":80,"status":51,"city":81,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"University Hospitals Coventry and Warwickshire NHS Trust,","Coventry",{"type":56,"coordinates":83},[84,85],-1.51217,52.40656,{"lat":85,"lon":84},[88,91],{"name":89,"role":43,"phone":26,"phoneExt":26,"email":90},"Michael Michael","Michael.Kuehl@uhcw.nhs.uk",{"name":92,"role":34,"phone":26,"phoneExt":26,"email":26},"Michael Kuehl",{"facility":94,"status":51,"city":95,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Croydon University Hospital - Croydon Health Services","Croydon",{"type":56,"coordinates":97},[98,99],-0.1,51.38333,{"lat":99,"lon":98},[102,105],{"name":103,"role":43,"phone":26,"phoneExt":26,"email":104},"Ravi Kamdar","ravi.kamdar@nhs.net",{"name":103,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":107,"status":51,"city":108,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Glenfield Hospital","Leicester",{"type":56,"coordinates":110},[111,112],-1.13169,52.6386,{"lat":112,"lon":111},[115,118],{"name":116,"role":43,"phone":26,"phoneExt":26,"email":117},"Ibrahim Mokhtar","mokhtar.ibrahim@uhl-tr.nhs.uk",{"name":116,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":120,"status":51,"city":121,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Hammersmith Hospital","London",{"type":56,"coordinates":123},[124,125],-0.12574,51.50853,{"lat":125,"lon":124},[128],{"name":33,"role":43,"phone":26,"phoneExt":26,"email":26},{"facility":130,"status":51,"city":121,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"King's College Hospital",{"type":56,"coordinates":132},[124,125],{"lat":125,"lon":124},[135,138],{"name":136,"role":43,"phone":26,"phoneExt":26,"email":137},"Paul Scott","paulscott3@nhs.net",{"name":136,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":140,"status":51,"city":121,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"St Bartholomew's Hospital - Barts Health NHS Trust",{"type":56,"coordinates":142},[124,125],{"lat":125,"lon":124},[145,148],{"name":146,"role":43,"phone":26,"phoneExt":26,"email":147},"Amal Muthumala","a.muthumala@nhs.net",{"name":146,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":150,"status":51,"city":151,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Oxford University Hospitals","Oxford",{"type":56,"coordinates":153},[154,155],-1.25596,51.75222,{"lat":155,"lon":154},[158,161],{"name":159,"role":43,"phone":26,"phoneExt":26,"email":160},"Julian Ormerod","Julian.Ormerod@ouh.nhs.uk",{"name":159,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":163,"status":51,"city":164,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"University Hospitals Southampton","Southampton",{"type":56,"coordinates":166},[167,168],-1.40428,50.90395,{"lat":168,"lon":167},[171,174],{"name":172,"role":43,"phone":26,"phoneExt":26,"email":173},"John Paisey","john.paisey@uhs.nhs.uk",{"name":172,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":176,"status":51,"city":177,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Great Western Hospitals","Swindon",{"type":56,"coordinates":179},[180,181],-1.78116,51.55797,{"lat":181,"lon":180},[184,187],{"name":185,"role":43,"phone":26,"phoneExt":26,"email":186},"Badri Chandrasekaran","badri.chandrasekaran1@nhs.net",{"name":185,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":189,"status":51,"city":190,"state":26,"zip":26,"country":53,"countryCode":54,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Worthing Hospital - University Hospitals Sussex","Worthing",{"type":56,"coordinates":192},[193,194],-0.37538,50.81795,{"lat":194,"lon":193},[197,200],{"name":198,"role":43,"phone":26,"phoneExt":26,"email":199},"Marian Bencat","marian.bencat@nhs.net",{"name":198,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":202,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100520123","physiological-versus-right-ventricular-outcome-trial-evaluated-for-bradycardia-treatment-upgrades-100520123",false,"NCT06052475","Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades","PROTECT-UP","Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (\\>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:\n\n1. EF reduced by \\>5% of increase in LVESV by 10ml since implant\n2. NT-proBNP \\>250ng\u002FL in sinus rhythm\n3. NT-proBNP \\> 750 Ng\u002FL if AF\n4. Left atrial volume index \\> 30ml\u002Fm2\n5. Regular loop diuretics prescribed\n6. Decline in daily patient activity by \\>1 hour per day since implant\n7. Decrease in device measured thoracic impedance\n8. Patient reported decline in functional class or exercise tolerance\n\nExclusion Criteria:\n\n* Those unable to provide informed consent\n* Patients under age 18\n* Pregnant women","ALL","18 Years",{"count":213,"type":214},155,"ESTIMATED","INTERVENTIONAL",[217],"NA","Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.\n\nHowever, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.\n\nThis trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.\n\nIn this crossover trial, participants will be upgraded to a physiological pacing strategy.\n\nAfter their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).\n\nThey will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.\n\nPatients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.\n\nThe investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.",[220,221],"Pacing-Induced Cardiomyopathy","Heart Failure",[223,224,225,226],"Physiological Pacing","RV Pacing","Biventricular Pacing","Pacemaker Upgrade","2026-06-22",{"date":229,"type":230},"2026-06-23","ACTUAL",{"date":232,"type":230},"2023-09-04",{"date":234,"type":214},"2027-09-04",{"name":5,"class":6},12]