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

Conditions: Arrythmia, Cardiomyopathies

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: PHASE4

Enrollment: 100

Sponsor: University of Rochester

Location: Banner University Medical Center Phoenix Arizona

Summary

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

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05034432). StuddyBuddy aggregates publicly available trial information.