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The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
RecruitingPhase 4
Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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
What is being tested
- Intra-Op Prophylactic VT ablation (procedure)
- Conventional Management (other)
Sponsor: University of Rochester · Participants: 100 · Started: May 27, 2022
Contact the study team
- Ann Colasurdo · Phone: 585-275-1054
- Kathy Honsinger · Phone: 585-273-1899
Official record on ClinicalTrials.gov — NCT05034432
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.