[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05034432":3,"trial-entities:NCT05034432":370,"trial-summary:NCT05034432":375},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":44,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":73,"locations":76,"central_contacts":353,"overall_officials":361,"references":364,"see_also_links":369},"NCT05034432","STUDY00006159","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)","RECRUITING","2027-06-30","2026-03","2026-07-14","2022-05-27","University of Rochester","OTHER",false,"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","This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA who will be randomized in a 1:1 ratio to intra-operative VTA ablation vs. conventional medical management. Comprehensive data on arrhythmia history, medication history will be collected in all randomized subjects. Antiarrhythmic medical therapy will be handled in a uniform pattern between the two arms. Randomized subjects will then be followed per routine schedules for post LVAD implant. Arrhythmia data, ICD therapy, additional procedures including repeat surgery, ramp echocardiographic tests, right heart catheterization and catheter-based VTA ablation will be collected. In addition, adverse events such as unplanned hospitalizations, emergency department visits, clinic visits, and all other aspects of health care utilization will be gathered. The planned average follow-up period will be 18 months.",[19,20],"Arrythmia","Cardiomyopathies",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},100,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"PROCEDURE","Intra-Op Prophylactic VT ablation","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",[32],{"type":14,"name":36,"description":37,"armGroupLabels":38},"Conventional Management","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",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Recurrent VTA","Total VTA events, after accounting for the competing risk of death","Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)",[45,49,52,54,57],{"measure":46,"description":47,"timeFrame":48},"Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.","Number of participants with any of the following: hospitalization, stroke or right heart failure. Right heart failure assessed by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria.","Post LVAD implant until end of follow-up, approximately 18 months",{"measure":50,"timeFrame":51},"Mean duration of LVAD implant (and ablation) surgery","Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)",{"measure":53,"timeFrame":51},"Mean duration of ablation",{"measure":55,"description":56,"timeFrame":51},"Mean rate of peri-procedural complication","Peri-procedural complications include bleeding, infection, and need for repeat operation.",{"measure":58,"timeFrame":51},"Mean Length of stay in the intensive care unit after LVAD implant","ALL","18 Years",null,{"inclusion":63,"exclusion":68,"raw_text":72},[64,65,66,67],"Age \\> 18 years","Presence of advanced cardiomyopathy (of all INTERMACS classification) and eligible for LVAD implant per the decision of the Heart Failure clinical team","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","History of treated or monitored sustained (i.e., \\>30 seconds in duration ) VT or VF episode within the past 5 years.",[69,70,71],"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)","Participation in other clinical trials (observational registries are allowed with approval)","Unable or unwilling to provide informed consent","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",[74,75],"ADULT","OLDER_ADULT",[77,95,110,124,139,154,165,180,195,210,225,240,254,265,279,294,308,323,338],{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":92},"Banner University Medical Center","Phoenix","Arizona","85006","United States",[84,89],{"name":85,"role":86,"phone":87,"email":88},"Matt Freeman","CONTACT","623-293-3945","mathew.freeman@bannerhealth.com",{"name":90,"role":91},"Roderick Tung","PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},33.44838,-112.07404,{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":82,"contacts":100,"geoPoint":107},"UCLA Cardiac Arrthmia Center","Los Angeles","California","90095",[101,105],{"name":102,"role":86,"phone":103,"email":104},"Julie Sorg","310-259-7327","jsorg@mednet.ucla.edu",{"name":106,"role":91},"Kalyanam Shivkumar",{"lat":108,"lon":109},34.05223,-118.24368,{"facility":111,"status":8,"city":112,"state":98,"zip":113,"country":82,"contacts":114,"geoPoint":121},"University of California San Francisco","San Francisco","94143",[115,119],{"name":116,"role":86,"phone":117,"email":118},"Maria Eleni Varympopioti","415-910-5046","mariaeleni.varympopioti@ucsf.edu",{"name":120,"role":91},"Joshua Moss",{"lat":122,"lon":123},37.77493,-122.41942,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":82,"contacts":129,"geoPoint":136},"Medstar Washington Hospital Center","Washington D.C.","District of Columbia","20010",[130,134],{"name":131,"role":86,"phone":132,"email":133},"Jamie Guillergan","202-877-5902","jamie.s.guillergan@medstar.net",{"name":135,"role":91},"Keki Balsara",{"lat":137,"lon":138},38.89511,-77.03637,{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":82,"contacts":144,"geoPoint":151},"Piedmont Heart Institute","Atlanta","Georgia","30309",[145,149],{"name":146,"role":86,"phone":147,"email":148},"Megan Kopp","404-605-5003","megan.kopp@piedmont.org",{"name":150,"role":91},"Ahmadreza Karimianpour",{"lat":152,"lon":153},33.749,-84.38798,{"facility":155,"status":8,"city":141,"state":142,"zip":156,"country":82,"contacts":157,"geoPoint":164},"Emory University","30322",[158,162],{"name":159,"role":86,"phone":160,"email":161},"Jovita Brevard","404-712-5992","jovita.johnson@emory.edu",{"name":163,"role":91},"Anand Shah",{"lat":152,"lon":153},{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":82,"contacts":170,"geoPoint":177},"Ascension St. Vincent Indianapolis","Indianapolis","Indiana","46260",[171,175],{"name":172,"role":86,"phone":173,"email":174},"Regina Margiotti","317-338-6151","regina.margiotti@ascension.org",{"name":176,"role":91},"Sunit-Preet Chaudhry",{"lat":178,"lon":179},39.76838,-86.15804,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":82,"contacts":185,"geoPoint":192},"Univedrsity of Louisville","Louisville","Kentucky","40202",[186,190],{"name":187,"role":86,"phone":188,"email":189},"Julie Caswell","502-587-4177","julie.caswell@louisville.edu",{"name":191,"role":91},"Auras Ravi Atreya",{"lat":193,"lon":194},38.25424,-85.75941,{"facility":196,"status":8,"city":197,"state":198,"zip":199,"country":82,"contacts":200,"geoPoint":207},"Johns Hopkins University","Baltimore","Maryland","21287",[201,205],{"name":202,"role":86,"phone":203,"email":204},"Zyriah Robinson","443-927-3983","zyriah.robinson@jhmi.edu",{"name":206,"role":91},"Chetan Pasrija",{"lat":208,"lon":209},39.29038,-76.61219,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":82,"contacts":215,"geoPoint":222},"Tufts Medical Center","Boston","Massachusetts","02111",[216,220],{"name":217,"role":86,"phone":218,"email":219},"Juan Carlos Collado Falcon","617-636-7433","juan.carlos.collado.falcon@tuftsmedicine.org",{"name":221,"role":91},"Guy Rozen",{"lat":223,"lon":224},42.35843,-71.05977,{"facility":226,"status":8,"city":227,"state":228,"zip":229,"country":82,"contacts":230,"geoPoint":237},"Henry Ford Health","Detroit","Michigan","48202",[231,235],{"name":232,"role":86,"phone":233,"email":234},"Briita Wanhala","313-916-9575","bwanhal1@hfhs.org",{"name":236,"role":91},"Arfaat Khan",{"lat":238,"lon":239},42.33143,-83.04575,{"facility":241,"status":8,"city":242,"state":242,"zip":243,"country":82,"contacts":244,"geoPoint":251},"Columbia University Medical Center","New York","10026",[245,249],{"name":246,"role":86,"phone":247,"email":248},"Jessica Idumonyi","212-305-1429","joi2102@cumc.columbia.edu",{"name":250,"role":91},"Nir Uriel",{"lat":252,"lon":253},40.71427,-74.00597,{"facility":13,"status":8,"city":255,"state":242,"zip":256,"country":82,"contacts":257,"geoPoint":262},"Rochester","14642",[258,260],{"name":259,"role":86},"Lori Caufield",{"name":261,"role":91},"Sabu Thomas",{"lat":263,"lon":264},43.15478,-77.61556,{"facility":266,"status":8,"city":267,"state":268,"zip":269,"country":82,"contacts":270,"geoPoint":276},"Cleveland Clinic","Cleveland","Ohio","44195",[271,274],{"name":272,"role":86,"phone":273},"Raquel Rozich","216-444-4959",{"name":275,"role":91},"Jakub Sroubek",{"lat":277,"lon":278},41.4995,-81.69541,{"facility":280,"status":8,"city":281,"state":282,"zip":283,"country":82,"contacts":284,"geoPoint":291},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[285,289],{"name":286,"role":86,"phone":287,"email":288},"Mary Gnap","215-349-8446","mary.gnap@pennmedicine.upenn.edu",{"name":290,"role":91},"Greg Supple",{"lat":292,"lon":293},39.95238,-75.16362,{"facility":295,"status":8,"city":296,"state":282,"zip":297,"country":82,"contacts":298,"geoPoint":305},"UPMC","Pittsburgh","15213",[299,303],{"name":300,"role":86,"phone":301,"email":302},"Rachel Mcgargle","412-864-0788","mcgarglerd@upmc.edu",{"name":304,"role":91},"Krishna Kancharla",{"lat":306,"lon":307},40.44062,-79.99589,{"facility":309,"status":8,"city":310,"state":311,"zip":312,"country":82,"contacts":313,"geoPoint":320},"Medical University of South Carolina","Charleston","South Carolina","29425",[314,318],{"name":315,"role":86,"phone":316,"email":317},"Hannah Culpepper","843-792-7244","culpepph@musc.edu",{"name":319,"role":91},"Arman Kilic",{"lat":321,"lon":322},32.77632,-79.93275,{"facility":324,"status":8,"city":325,"state":326,"zip":327,"country":82,"contacts":328,"geoPoint":335},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",[329,333],{"name":330,"role":86,"phone":331,"email":332},"Lisa Slinger","615-385-2602","lisa.slinger@vumc.org",{"name":334,"role":91},"Sandip Zalawadiya",{"lat":336,"lon":337},36.16589,-86.78444,{"facility":339,"status":8,"city":340,"state":341,"zip":342,"country":82,"contacts":343,"geoPoint":350},"Houston Methodist Hospital","Houston","Texas","77030",[344,348],{"name":345,"role":86,"phone":346,"email":347},"Chinwe Ngumezi","346-238-0290","ccngumezi@houstonmethodist.org",{"name":349,"role":91},"Nilesh Mathuria",{"lat":351,"lon":352},29.76328,-95.36327,[354,358],{"name":355,"role":86,"phone":356,"email":357},"Ann Colasurdo","585-275-1054","ann_colasurdo@urmc.rochester.edu",{"name":359,"role":86,"phone":360},"Kathy Honsinger","585-273-1899",[362],{"name":363,"affiliation":13,"role":91},"David Huang, MD",[365],{"pmid":366,"type":367,"citation":368},"38103723","DERIVED","Oates CP, Lam PH, Lawrence L, Bigham G, Meda NS, Basyal B, Hadadi CA, Rao SD, Hockstein M, Shah M, Sheikh FH. Early Ventricular Arrhythmias After Left Ventricular Assist Device Implantation. J Card Fail. 2024 Aug;30(8):1018-1027. doi: 10.1016\u002Fj.cardfail.2023.11.018. Epub 2023 Dec 15.",[],{"nct_id":4,"conditions":371,"biomarkers":374},[372,373],"Arrhythmia","Cardiomyopathy",[],{"nct_id":4,"found":376,"summary":377,"prompt_version":387},true,{"design":378,"status":379,"heading":380,"summary":381,"follow_up":382,"word_count":383,"commitments":384,"compensation":385,"drugs_mentioned":386},"This is a randomized controlled trial, meaning participants are randomly assigned to one of two groups: intra-operative VTA ablation or conventional medical management. It is an open-label study, so both you and your doctors will know which treatment you are receiving, and it plans to enroll 100 participants.","completed","The PIVATAL Study: Ventricular Arrhythmia Ablation in LVAD Patients","This study, called The PIVATAL Study, is looking at whether a procedure called intra-operative VTA ablation (a surgery to treat abnormal heart rhythms) can reduce the number of abnormal heart rhythms (ventricular arrhythmias or VTA) in people who are getting a left ventricular assist device (LVAD) implant. You might be able to join if you are over 18, have advanced cardiomyopathy (a heart muscle disease), are eligible for an LVAD, and have an implanted cardioverter defibrillator (ICD) or plan to get one. The study compares the VTA ablation procedure to conventional medical management, which includes antiarrhythmic drugs like amiodarone, sotalol, or dofetilide. The main goal is to see if the ablation reduces recurrent VTA after your LVAD implant. The current status of the study is unclear, and it plans to enroll 100 participants.","Participants will be followed for an average of 18 months (with a minimum of 6 months) after their LVAD implant to track recurrent ventricular arrhythmias.",133,"You will be followed per routine schedules after your LVAD implant, with data collected on your heart rhythm, ICD therapy, and other medical events. The planned average follow-up period is 18 months.","Not stated in the trial record.",[],"v2"]