[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477030":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":36,"responsibleParty":55,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Miulli General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High intensity His bundle pacing","EXPERIMENTAL","After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 3.5V\u002F1msec.\n\nAfter one month these patients will continue to receive active pacing treatment with 3.5V\u002F1msec.",[13],"Device: High Intensity His Bundle pacing",{"label":15,"type":16,"description":17,"interventionNames":18},"Back up only ventricular pacing","SHAM_COMPARATOR","After implantation of the device there will be a 1-month run-in period that the device will be programmed to deliver His bundle pacing therapy during this period at 2V\u002F1msec.\n\nAfter one month these patients will receive back up only pacing (pacemaker programmed to VVI 30 bpm or AAI(R)-DDD(R) 50bpm) for 6 months.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","High Intensity His Bundle pacing","All patients will be implanted with an Implantable cardioverter defibrillator (ICD) and an ICD lead in the right ventricle (either RV apex or RV septum). In all patients a pacing lead will be positioned in the right atrium (typically the right atrial appendage). All patients will have a pacemaker lead positioned on the His bundle to obtain direct His-bundle capture.",[15,9],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Grigorios Katsouras, MD, MSc","CONTACT","0803054219","g.katsouras@miulli.it",{"name":33,"role":29,"phone":34,"phoneExt":25,"email":35},"Pietro Guida","0803054029","p.guida@miulli.it",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Acquaviva delle Fonti","Bari","70021","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],16.8433,40.89704,{"lat":48,"lon":47},[51,53],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":52},"gkatsouras@me.com",{"name":54,"role":29,"phone":34,"phoneExt":25,"email":35},"Piero Guida",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Grigorios Katsouras","Cardiologist, Principal Investigator","100477030","high-intensity-his-bundle-pacing-in-heart-failure-patients-with-narrow-qrs-outcome-study-100477030",false,"NCT05491655","High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study","HIPPOS","Inclusion Criteria:\n\n* Aged 18 or above\n* Ventricular Ejection Fraction (EF) \\\u003C 50%; BNP needs to be ≥250ng\u002FL or N Terminal-pro BNP≥600ng\u002FL for patients with EF 36-50% and they should have an ICD indication\n* New York Heart Association (NYHA) class I-IV\n* Narrow QRS duration (≤110ms) on 12 lead ECG\n\nExclusion Criteria:\n\n* Other serious medical condition with life expectancy of less than 1 year\n* Lack of capacity to consent\n* Pregnancy\n* Previous aortic valve surgery","ALL","18 Years","90 Years",{"count":70,"type":71},34,"ESTIMATED","INTERVENTIONAL",[74],"NA","Cardiac Resynchronization Therapy (CRT) decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction (EF) in patients with dilated cardiomyopathy, left bundle branch block and QRS duration \\>130msec. His bundle pacing has a similar effect in this category of patients. However, CRT is not beneficial in heart failure (HF) patients with narrow QRS. His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure, a prolonged PR interval, and either a narrow QRS or RBBB through AV delay optimization. We observed an acute hemodynamic effect during application of higher pacing output (3.5 Volts\u002F1 msec) in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening.\n\nThis is a single-center, prospective randomized single-blinded study, recruiting a sub-population of patients with heart failure (dilated or ischemic cardiomyopathy, EF\\\u003C50%, narrow QRS (\\\u003C110 msec), in optimal medical treatment who have an indication for ICD.",[77,78,79,80],"Cardiac Conduction System","His Bundle Pacing","Heart Failure","Cardiomyopathies",[82,83,84,85,86,87],"His bundle pacing","conduction system pacing","Heart failure","Cardiomyopathy","narrow QRS","Ejection Fraction","2025-12-15",{"date":90,"type":91},"2025-12-22","ACTUAL",{"date":93,"type":91},"2023-03-29",{"date":95,"type":71},"2026-05",{"name":5,"class":6},1]