[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441903":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":41,"responsibleParty":357,"collaborators":360,"id":364,"slug":365,"hasResults":366,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":366,"sex":372,"minAge":373,"maxAge":25,"enrollmentInfo":374,"targetDuration":25,"studyType":377,"phases":378,"briefSummary":380,"conditions":381,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":393},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intra-Op Prophylactic VT ablation","EXPERIMENTAL","Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support",[13],"Procedure: Intra-Op Prophylactic VT ablation",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Management","ACTIVE_COMPARATOR","To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued",[19],"Other: Conventional Management",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","For surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and\u002For echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping",[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"David Huang, MD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Ann Colasurdo","CONTACT","585-275-1054","ann_colasurdo@urmc.rochester.edu",{"name":39,"role":35,"phone":40,"phoneExt":25,"email":25},"Kathy Honsinger","585-273-1899",[42,63,80,96,113,130,143,160,177,194,211,228,244,257,273,290,306,323,340],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Banner University Medical Center","RECRUITING","Phoenix","Arizona","85006","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-112.07404,33.44838,{"lat":54,"lon":53},[57,61],{"name":58,"role":35,"phone":59,"phoneExt":25,"email":60},"Matt 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Varympopioti","415-910-5046","mariaeleni.varympopioti@ucsf.edu",{"name":95,"role":31,"phone":25,"phoneExt":25,"email":25},"Joshua Moss",{"facility":97,"status":44,"city":98,"state":99,"zip":100,"country":48,"countryCode":49,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Medstar Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"type":51,"coordinates":102},[103,104],-77.03637,38.89511,{"lat":104,"lon":103},[107,111],{"name":108,"role":35,"phone":109,"phoneExt":25,"email":110},"Jamie Guillergan","202-877-5902","jamie.s.guillergan@medstar.net",{"name":112,"role":31,"phone":25,"phoneExt":25,"email":25},"Keki Balsara",{"facility":114,"status":44,"city":115,"state":116,"zip":117,"country":48,"countryCode":49,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Piedmont Heart 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Hopkins University","Baltimore","Maryland","21287",{"type":51,"coordinates":183},[184,185],-76.61219,39.29038,{"lat":185,"lon":184},[188,192],{"name":189,"role":35,"phone":190,"phoneExt":25,"email":191},"Zyriah Robinson","443-927-3983","zyriah.robinson@jhmi.edu",{"name":193,"role":31,"phone":25,"phoneExt":25,"email":25},"Chetan Pasrija",{"facility":195,"status":44,"city":196,"state":197,"zip":198,"country":48,"countryCode":49,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Tufts Medical Center","Boston","Massachusetts","02111",{"type":51,"coordinates":200},[201,202],-71.05977,42.35843,{"lat":202,"lon":201},[205,209],{"name":206,"role":35,"phone":207,"phoneExt":25,"email":208},"Juan Carlos Collado Falcon","617-636-7433","juan.carlos.collado.falcon@tuftsmedicine.org",{"name":210,"role":31,"phone":25,"phoneExt":25,"email":25},"Guy 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Uriel",{"facility":5,"status":44,"city":245,"state":230,"zip":246,"country":48,"countryCode":49,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Rochester","14642",{"type":51,"coordinates":248},[249,250],-77.61556,43.15478,{"lat":250,"lon":249},[253,255],{"name":254,"role":35,"phone":25,"phoneExt":25,"email":25},"Lori Caufield",{"name":256,"role":31,"phone":25,"phoneExt":25,"email":25},"Sabu Thomas",{"facility":258,"status":44,"city":259,"state":260,"zip":261,"country":48,"countryCode":49,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":51,"coordinates":263},[264,265],-81.69541,41.4995,{"lat":265,"lon":264},[268,271],{"name":269,"role":35,"phone":270,"phoneExt":25,"email":25},"Raquel Rozich","216-444-4959",{"name":272,"role":31,"phone":25,"phoneExt":25,"email":25},"Jakub 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Kancharla",{"facility":307,"status":44,"city":308,"state":309,"zip":310,"country":48,"countryCode":49,"cosmosGeoPoint":311,"geoPoint":315,"contacts":316},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":51,"coordinates":312},[313,314],-79.93275,32.77632,{"lat":314,"lon":313},[317,321],{"name":318,"role":35,"phone":319,"phoneExt":25,"email":320},"Hannah Culpepper","843-792-7244","culpepph@musc.edu",{"name":322,"role":31,"phone":25,"phoneExt":25,"email":25},"Arman Kilic",{"facility":324,"status":44,"city":325,"state":326,"zip":327,"country":48,"countryCode":49,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":51,"coordinates":329},[330,331],-86.78444,36.16589,{"lat":331,"lon":330},[334,338],{"name":335,"role":35,"phone":336,"phoneExt":25,"email":337},"Lisa Slinger","615-385-2602","lisa.slinger@vumc.org",{"name":339,"role":31,"phone":25,"phoneExt":25,"email":25},"Sandip Zalawadiya",{"facility":341,"status":44,"city":342,"state":343,"zip":344,"country":48,"countryCode":49,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Houston Methodist Hospital","Houston","Texas","77030",{"type":51,"coordinates":346},[347,348],-95.36327,29.76328,{"lat":348,"lon":347},[351,355],{"name":352,"role":35,"phone":353,"phoneExt":25,"email":354},"Chinwe Ngumezi","346-238-0290","ccngumezi@houstonmethodist.org",{"name":356,"role":31,"phone":25,"phoneExt":25,"email":25},"Nilesh Mathuria",{"type":31,"investigatorFullName":358,"investigatorTitle":359,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"David Huang","Professor",[361],{"name":362,"class":363},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100441903","phase-4-the-pivatal-study--study-of-ventricular-arrhythmia-vta-ablation-in-left-ventricular-assist-device-lvad-patients-100441903",false,"NCT05034432","The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients","Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)","PIVATAL","Inclusion Criteria:\n\n* Age \\> 18 years\n* Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team\n* Implanted cardioverter defibrillator (ICD) any time in past with remote monitoring or planned to undergo ICD (or ICM as an alternative, if an ICD cannot be implanted for a clinical reason) implant within the index hospitalization for LVAD implant\n* History of treated or monitored sustained (i.e., \\>30 seconds in duration ) VT or VF episode within the past 5 years.\n\nExclusion Criteria:\n\n* Past successful VTA ablation without recurrent VTA prior to LVAD implant (Patients who continue to experience VTA post ablation and pre LVAD implant qualify to be enrolled)\n* Participation in other clinical trials (observational registries are allowed with approval)\n* Unable or unwilling to provide informed consent","ALL","18 Years",{"count":375,"type":376},100,"ESTIMATED","INTERVENTIONAL",[379],"PHASE4","To investigate the effect of VTA ablation at the time of LVAD implant to see if it can reduce the incidence of VTA after surgery",[382,383],"Arrythmia","Cardiomyopathies","2026-03-19",{"date":386,"type":387},"2026-03-23","ACTUAL",{"date":389,"type":387},"2022-05-27",{"date":391,"type":376},"2027-06-30",{"name":5,"class":6},19]