[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07005232":3,"trial-entities:NCT07005232":585,"trial-summary:NCT07005232":588},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":22,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":39,"std_ages":49,"locations":53,"central_contacts":581,"overall_officials":582,"references":583,"see_also_links":584},"NCT07005232","LEADR PAS","Lead Evaluation for Defibrillation and Reliability Post Approval Study","Lead Evaluation for Defibrillation and Reliability Post Approval Study (LEADR PAS)","ENROLLING_BY_INVITATION","2032-09","2026-07","2026-08-03","2026-01-07","Medtronic","INDUSTRY",false,"Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).","The LEADR PAS is a global, prospective, observational, multi-site registry study. This study is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).\n\nEligibility for enrollment is based on market release dates for the OmniaSecure™ defibrillation lead within the geography in which the subject is enrolled.\n\nPatients enrolled in LEADR PAS will be prospectively followed for the lifetime of device post-implant or until registry closure, patient death, or patient exit from the registry (i.e., withdrawal of consent).\n\nSuccessfully implanted patients are expected to have scheduled follow-up visits per routine clinical care, at least annually, or as prompted by reportable adverse events. The primary objective analysis will occur when 500 patients reach 5 years of follow-up. The total estimated registry duration is through lifetime of device.",[19],"Tachyarrhythmia",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},2000,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"DEVICE","defibrillation lead","This is a device registry for the OmniaSecure™ defibrillation lead. The OmniaSecure lead is a steroid eluting, integrated bipolar, nonretractable screw-in, catheter delivered, transvenous ventricular lead with a Right Ventricular (RV) defibrillation coil electrode. The lead is designed for pacing, sensing, cardioversion, and defibrillation therapies, and has application for patients whom transvenous ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated.",[33],{"measure":34,"description":35,"timeFrame":36},"Complication Survival Rate","Estimate OmniaSecure lead-related complication-free survival through 5 years post implant.","5 years",[],"ALL",{"inclusion":40,"exclusion":44,"raw_text":48},[41,42,43],"Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements","Patient has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.","Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study",[45,46,47],"Patient who is, or is expected to be, inaccessible for follow-up","Patient is excluded by local local law","Patient is currently enrolled or plans to enroll in any concurrent drug and\u002For device study that may confound the Product Surveillence Registyr (PSR) results","Inclusion Criteria:\n\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n* Patient has, or is intended to receive or be treated with an OmniaSecure™ defibrillation lead.\n* Patient is consented prior to or within 30 days of the therapy received or consented as continuation from the LEADR Pivotal study\n\nExclusion Criteria:\n\n* Patient who is, or is expected to be, inaccessible for follow-up\n* Patient is excluded by local local law\n* Patient is currently enrolled or plans to enroll in any concurrent drug and\u002For device study that may confound the Product Surveillence Registyr (PSR) results",[50,51,52],"CHILD","ADULT","OLDER_ADULT",[54,63,71,78,86,94,102,110,117,124,131,138,146,154,162,170,178,185,193,200,208,215,219,226,233,241,247,254,262,270,278,286,293,299,303,310,318,325,333,340,347,355,362,369,376,384,388,396,403,406,414,421,429,437,446,454,461,468,475,482,489,496,503,510,517,524,532,539,546,553,560,568,575],{"facility":55,"city":56,"state":57,"zip":58,"country":59,"geoPoint":60},"The University of Alabama at Birmingham","Birmingham","Alabama","35233","United States",{"lat":61,"lon":62},33.52066,-86.80249,{"facility":64,"city":65,"state":66,"zip":67,"country":59,"geoPoint":68},"Stanford Hospital & Clinics","Stanford","California","64305-2200",{"lat":69,"lon":70},37.42411,-122.16608,{"facility":72,"city":73,"state":66,"zip":74,"country":59,"geoPoint":75},"COR Healthcare","Torrance","90505- 5100",{"lat":76,"lon":77},33.83585,-118.34063,{"facility":79,"city":80,"state":81,"zip":82,"country":59,"geoPoint":83},"Childrens Hospital 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Harbor","34695",{"lat":122,"lon":123},27.99085,-82.69316,{"facility":125,"city":126,"state":105,"zip":127,"country":59,"geoPoint":128},"Intercoastal Medical Group","Sarasota","34233",{"lat":129,"lon":130},27.33643,-82.53065,{"facility":132,"city":133,"state":105,"zip":134,"country":59,"geoPoint":135},"University of South Florida Health (USF)","Tampa","33612",{"lat":136,"lon":137},27.94752,-82.45843,{"facility":139,"city":140,"state":141,"zip":142,"country":59,"geoPoint":143},"WellStar Research Institute","Marietta","Georgia","30060",{"lat":144,"lon":145},33.9526,-84.54993,{"facility":147,"city":148,"state":149,"zip":150,"country":59,"geoPoint":151},"Deaconess Specialty Physicians","Newburgh","Indiana","47630",{"lat":152,"lon":153},37.94449,-87.40529,{"facility":155,"city":156,"state":157,"zip":158,"country":59,"geoPoint":159},"Iowa Heart Center (West Des Moines IA)","West Des Moines","Iowa","50266-8209",{"lat":160,"lon":161},41.57721,-93.71133,{"facility":163,"city":164,"state":165,"zip":166,"country":59,"geoPoint":167},"University of Kansas Medical Center Research Institute","Kansas City","Kansas","66160-8500",{"lat":168,"lon":169},39.11417,-94.62746,{"facility":171,"city":172,"state":173,"zip":174,"country":59,"geoPoint":175},"Saint Elizabeth Healthcare","Edgewood","Kentucky","41017",{"lat":176,"lon":177},39.01867,-84.58189,{"facility":179,"city":180,"state":173,"zip":181,"country":59,"geoPoint":182},"Norton Heart and Vascular Institute","Louisville","40205",{"lat":183,"lon":184},38.25424,-85.75941,{"facility":186,"city":187,"state":188,"zip":189,"country":59,"geoPoint":190},"Sparrow Clinical Research Institute","Lansing","Michigan","48912",{"lat":191,"lon":192},42.73253,-84.55553,{"facility":194,"city":195,"state":188,"zip":196,"country":59,"geoPoint":197},"Michigan Heart","Ypsilanti","48197",{"lat":198,"lon":199},42.24115,-83.61299,{"facility":201,"city":202,"state":203,"zip":204,"country":59,"geoPoint":205},"Metropolitan Cardiology Consultants","Coon Rapids","Minnesota","55433-4568",{"lat":206,"lon":207},45.11997,-93.28773,{"facility":209,"city":210,"state":203,"zip":211,"country":59,"geoPoint":212},"Minneapolis Heart Institute Foundation","Minneapolis","55407",{"lat":213,"lon":214},44.97997,-93.26384,{"facility":216,"city":210,"state":203,"zip":217,"country":59,"geoPoint":218},"M Health Fairview University of Minnesota Medical Center - East Bank","55455",{"lat":213,"lon":214},{"facility":220,"city":221,"state":203,"zip":222,"country":59,"geoPoint":223},"North Memorial Health Heart & Vascular Center","Robbinsdale","55422-4391",{"lat":224,"lon":225},45.03219,-93.33856,{"facility":227,"city":228,"state":203,"zip":229,"country":59,"geoPoint":230},"Mayo Clinic (Rochester 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Jersey","08053",{"lat":268,"lon":269},39.89122,-74.92183,{"facility":271,"city":272,"state":273,"zip":274,"country":59,"geoPoint":275},"Presbyterian Heart Group","Albuquerque","New Mexico","87106",{"lat":276,"lon":277},35.08449,-106.65114,{"facility":279,"city":280,"state":281,"zip":282,"country":59,"geoPoint":283},"Northwell Health South Shore University Hospital","Bay Shore","New York","11706",{"lat":284,"lon":285},40.7251,-73.24539,{"facility":287,"city":288,"state":281,"zip":289,"country":59,"geoPoint":290},"Northwell Health Huntington Hospital","Huntington","11743-2787",{"lat":291,"lon":292},40.86815,-73.42568,{"facility":294,"city":281,"state":281,"zip":295,"country":59,"geoPoint":296},"Northwell Health North Shore University Hospital","10075",{"lat":297,"lon":298},40.71427,-74.00597,{"facility":300,"city":281,"state":281,"zip":301,"country":59,"geoPoint":302},"Long Island Jewish Medical Center","11040",{"lat":297,"lon":298},{"facility":304,"city":305,"state":281,"zip":306,"country":59,"geoPoint":307},"Northwell Health Staten Island University Hospital","Staten Island","10305-3400",{"lat":308,"lon":309},40.56233,-74.13986,{"facility":311,"city":312,"state":313,"zip":314,"country":59,"geoPoint":315},"Duke University Medical Center (DUMC)","Durham","North Carolina","27705-4699",{"lat":316,"lon":317},35.99403,-78.89862,{"facility":319,"city":320,"state":313,"zip":321,"country":59,"geoPoint":322},"WakeMed Health & Hospitals","Raleigh","27610",{"lat":323,"lon":324},35.7721,-78.63861,{"facility":326,"city":327,"state":328,"zip":329,"country":59,"geoPoint":330},"The Christ Hospital Health Network CRD","Cincinnati","Ohio","45219-2906",{"lat":331,"lon":332},39.12711,-84.51439,{"facility":334,"city":335,"state":328,"zip":336,"country":59,"geoPoint":337},"Cleveland Clinic Foundation","Cleveland","44195",{"lat":338,"lon":339},41.4995,-81.69541,{"facility":341,"city":342,"state":328,"zip":343,"country":59,"geoPoint":344},"The Ohio State University Wexner Medical Center","Columbus","43210-1252",{"lat":345,"lon":346},39.96118,-82.99879,{"facility":348,"city":349,"state":350,"zip":351,"country":59,"geoPoint":352},"Lehigh Valley Health Network","Allentown","Pennsylvania","18103",{"lat":353,"lon":354},40.60843,-75.49018,{"facility":356,"city":357,"state":350,"zip":358,"country":59,"geoPoint":359},"Geisinger Medical Center","Danville","17822-9800",{"lat":360,"lon":361},40.96342,-76.61273,{"facility":363,"city":364,"state":350,"zip":365,"country":59,"geoPoint":366},"The Childrens Hospital of Philadelphia CHOP","Philadelphia","19104",{"lat":367,"lon":368},39.95238,-75.16362,{"facility":370,"city":371,"state":350,"zip":372,"country":59,"geoPoint":373},"Geisinger Wyoming Valley Medical Center","Wilkes-Barre","18711",{"lat":374,"lon":375},41.24591,-75.88131,{"facility":377,"city":378,"state":379,"zip":380,"country":59,"geoPoint":381},"Saint Thomas Research Institute","Nashville","Tennessee","37205",{"lat":382,"lon":383},36.16589,-86.78444,{"facility":385,"city":378,"state":379,"zip":386,"country":59,"geoPoint":387},"Vanderbilt University Medical Center","37232",{"lat":382,"lon":383},{"facility":389,"city":390,"state":391,"zip":392,"country":59,"geoPoint":393},"Texas Cardiac Arrhythmia Research Foundation","Austin","Texas","78705",{"lat":394,"lon":395},30.26715,-97.74306,{"facility":397,"city":398,"state":391,"zip":399,"country":59,"geoPoint":400},"Consultants in Cardiology (Fort Worth TX)","Fort Worth","76104",{"lat":401,"lon":402},32.72541,-97.32085,{"facility":404,"city":398,"state":391,"zip":399,"country":59,"geoPoint":405},"Heart Center of North Texas",{"lat":401,"lon":402},{"facility":407,"city":408,"state":409,"zip":410,"country":59,"geoPoint":411},"University of Virginia Medical Center","Charlottesville","Virginia","22908",{"lat":412,"lon":413},38.02931,-78.47668,{"facility":415,"city":416,"state":409,"zip":417,"country":59,"geoPoint":418},"Inova Fairfax Hospital","Fairfax","22031-4867",{"lat":419,"lon":420},38.84622,-77.30637,{"facility":422,"city":423,"state":424,"zip":425,"country":59,"geoPoint":426},"Aurora Cardiovascular Services","Milwaukee","Wisconsin","53215",{"lat":427,"lon":428},43.0389,-87.90647,{"facility":430,"city":431,"zip":432,"country":433,"geoPoint":434},"Kepler Universitätsklinikum Med Campus III","Linz","4020","Austria",{"lat":435,"lon":436},48.30639,14.28611,{"facility":438,"city":439,"state":440,"zip":441,"country":442,"geoPoint":443},"Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)","Québec","Quebec","G1V4G5","Canada",{"lat":444,"lon":445},46.81228,-71.21454,{"facility":447,"city":448,"zip":449,"country":450,"geoPoint":451},"CHRU de Tours - Hôpital Trousseau","Chambray-lès-Tours","37170","France",{"lat":452,"lon":453},47.33537,0.70286,{"facility":455,"city":456,"zip":457,"country":450,"geoPoint":458},"Centre Hospitalier Universitaire de Grenoble - Site Nord","La Tronche","38700",{"lat":459,"lon":460},45.20507,5.74629,{"facility":462,"city":463,"zip":464,"country":450,"geoPoint":465},"Centre Hospitalier Régional Universitaire de Lille","Lille","59037",{"lat":466,"lon":467},50.63391,3.05512,{"facility":469,"city":470,"zip":471,"country":450,"geoPoint":472},"OC Santé - Clinique du Millénaire","Montpellier","34960",{"lat":473,"lon":474},43.61093,3.87635,{"facility":476,"city":477,"zip":478,"country":450,"geoPoint":479},"Hôpital Haut-Lévêque - CHU de Bordeaux","Pessac","33604",{"lat":480,"lon":481},44.80565,-0.6324,{"facility":483,"city":484,"zip":485,"country":450,"geoPoint":486},"CHU de Rennes - Hôpital Pontchaillou","Rennes","35033",{"lat":487,"lon":488},48.11109,-1.67431,{"facility":490,"city":491,"zip":492,"country":450,"geoPoint":493},"CHU Hôpitaux de Rouen - Hôpital Charles Nicolle","Rouen","6229 GW",{"lat":494,"lon":495},49.44313,1.09932,{"facility":497,"city":498,"zip":499,"country":450,"geoPoint":500},"Clinique Pasteur","Toulouse","31076",{"lat":501,"lon":502},43.60426,1.44367,{"facility":504,"city":505,"zip":478,"country":506,"geoPoint":507},"Klinikum Bielefeld","Bielefeld","Germany",{"lat":508,"lon":509},52.03333,8.53333,{"facility":511,"city":512,"zip":513,"country":506,"geoPoint":514},"Saint Vinzenz Hospital Köln","Cologne","50733",{"lat":515,"lon":516},50.93333,6.95,{"facility":518,"city":519,"zip":520,"country":506,"geoPoint":521},"Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum","Meerbusch","40670",{"lat":522,"lon":523},51.25268,6.68807,{"facility":525,"city":526,"state":526,"zip":527,"country":528,"geoPoint":529},"Hospital Universitario Virgen de las Nieves","Granada","18014","Spain",{"lat":530,"lon":531},37.18817,-3.60667,{"facility":533,"city":534,"zip":535,"country":528,"geoPoint":536},"Hospital Universitario da Coruña","A Coruña","15006",{"lat":537,"lon":538},43.37135,-8.396,{"facility":540,"city":541,"zip":542,"country":528,"geoPoint":543},"Hospital Universitario 12 de Octubre","Madrid","28050",{"lat":544,"lon":545},40.4165,-3.70256,{"facility":547,"city":548,"zip":549,"country":528,"geoPoint":550},"Hospital Universitario Nuestra Señora de Candelaria","Santa Cruz de Tenerife","38010",{"lat":551,"lon":552},28.46824,-16.25462,{"facility":554,"city":555,"zip":556,"country":528,"geoPoint":557},"Hospital Universitario y Politécnico La Fe","Valencia","46026",{"lat":558,"lon":559},39.47391,-0.37966,{"facility":561,"city":562,"zip":563,"country":564,"geoPoint":565},"Liverpool Heart and Chest Hospital NHS Foundation Trust","Liverpool","L143PE","United Kingdom",{"lat":566,"lon":567},53.41058,-2.97794,{"facility":569,"city":570,"zip":571,"country":564,"geoPoint":572},"Imperial College Healthcare NHS Trust - Hammersmith Hospital","London","W12OHS",{"lat":573,"lon":574},51.50853,-0.12574,{"facility":576,"city":577,"country":564,"geoPoint":578},"Southampton General Hospital - University Hospital Southampton NHS Foundation Trust","Southampton",{"lat":579,"lon":580},50.90395,-1.40428,[],[],[],[],{"nct_id":4,"conditions":586,"biomarkers":587},[19],[],{"nct_id":4,"found":15,"summary":22,"prompt_version":22}]