[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542409":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":33,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":67,"collaborators":17,"id":69,"slug":17,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":17,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":17,"enrollmentInfo":76,"targetDuration":17,"studyType":79,"phases":17,"briefSummary":80,"conditions":81,"keywords":17,"overallStatus":50,"whyStopped":17,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Kansas City Heart Rhythm Research Foundation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Need for lead revision","Compare the need for lead revision between conduction system pacing (CSP) and transthoracic left ventricular (LV) epicardial pacing approach","Procedure Day",[14],{"measure":15,"description":16,"timeFrame":12},"Electrocardiography characteristics - QRS Interval","Compare electrocardiography characteristics - QRS Interval measured in seconds between conduction system pacing (CSP) and transthoracic left ventricular (LV) epicardial pacing approach",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","RETROSPECTIVE","Cardiac resynchronization therapy with defibrillator(CRT-D) improves quality of life, functionality, and even mortality for select patients with severe heart failure with reduced ejection fraction (HFrEF). It traditionally consists of three leads placed endovascularly into the right atrium, right ventricle, and left ventricle (LV) \\[typically placed into the CS\\], known as biventricular pacing resynchronization (BVP-CRT), respectively, from which electrical stimulation enables improved cardiac synchrony. Nonetheless, the placement of a CRT-D is not without risks. Lead-related complication is high and CRT-D implantation fails in up to 30% of patients due to lead placement alone.\n\nEpicardial lead placement and CSP have been deemed viable alternatives to CRT-D. It has even been shown to be options in patients that fail conventional BVP-CRT. This is primarily due to increased accuracy, decreased complications, and even durability. However, guidelines for decision between a transthoracic approach and CSP is unclear, even more so after lead failure. Instead, this decision is currently individualized to the patient. There is a lack of prospective and head-to-head data between the two, and this study is aimed to compare transthoracic LV epicardial lead placement and CSP in patients with lead failure after BVP-CRT.","Adults who underwent CS lead revision, comparing epicardial lead placement to CSP in those that had lead failure.",[24,29],{"label":25,"type":17,"description":26,"interventionNames":27},"Conduction System Pacing","Subjects who had lead placement via conduction system pacing approach",[28],"Other: Coronary Sinus Lead Revision",{"label":30,"type":17,"description":31,"interventionNames":32},"Epicardial Lead Placement","Subjects who had lead placement via transthoracic, epicardial approach",[28],[34],{"type":6,"name":35,"description":35,"armGroupLabels":36,"otherNames":17},"Coronary Sinus Lead Revision",[25,30],[38],{"name":39,"affiliation":40,"role":41},"Naga Venkata K. Pothineni","Kansas City Heart Rhythm Institute","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":17,"email":47},"Donita Atkins","CONTACT","816-651-1969","datkins@kchrf.com",[49],{"facility":40,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Overland Park","Kansas","66211","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-94.67079,38.98223,{"lat":60,"lon":59},[63,65],{"name":44,"role":45,"phone":46,"phoneExt":17,"email":64},"Datkins@kchrf.com",{"name":66,"role":41,"phone":17,"phoneExt":17,"email":17},"Naga Venkata K. Pothineni, MD",{"type":68,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100542409",false,"NCT06342492","Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure","Inclusion Criteria:\n\n* All patients older than 18 years of age\n* Patients with HFrEF that underwent BVP-CRT\n* Experienced CS lead failure, whether initial or recurrent, subsequently replaced with transthoracic epicardial lead placement or CSP\n* Underwent Medtronic, Boston Scientific, or Abbott lead placement\n\nExclusion Criteria:\n\n* Patients younger than 18 years of age\n* Transthoracic epicardial lead placement or CSP performed as the initial approach or for other reasons than lead replacement\n* Those for which CRT no longer provides symptom relief or mortality benefit.","ALL","18 Years",{"count":77,"type":78},100,"ESTIMATED","OBSERVATIONAL","This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure.",[82],"Heart Failure With Reduced Ejection Fraction","2024-10-25",{"date":85,"type":86},"2024-10-28","ACTUAL",{"date":88,"type":86},"2023-11-07",{"date":90,"type":78},"2024-12",{"name":5,"class":6},1]