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The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Rochester
NCT05034432 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • Intra-Op Prophylactic VT ablation
  • Conventional Management
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Where

19 sites
Banner University Medical Center
Phoenix, United States
UCLA Cardiac Arrthmia Center
Los Angeles, United States
University of California San Francisco
San Francisco, United States
Medstar Washington Hospital Center
Washington D.C., United States
Piedmont Heart Institute
Atlanta, United States
Emory University
Atlanta, United States
Ascension St. Vincent Indianapolis
Indianapolis, United States
Univedrsity of Louisville
Louisville, United States

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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