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

Launched by UNIVERSITY OF ROCHESTER · Aug 29, 2021

Keywords

ClinConnect Summary

The PIVATAL Study is a clinical trial designed to study how a procedure called ventricular arrhythmia (VTA) ablation can help patients with heart problems who are getting a Left Ventricular Assist Device (LVAD). The goal is to see if performing this procedure at the same time as the LVAD surgery can lower the chances of patients experiencing serious heart rhythm problems after the surgery. The trial is currently looking for participants aged 18 and older who have severe heart disease and need an LVAD, and who have had a history of certain heart rhythm issues.

If you participate in this trial, you will receive care from a specialized heart failure clinical team. They will monitor your heart condition closely throughout the process. To be eligible, you should have a history of specific heart issues and may need to have an implanted device called a cardioverter defibrillator (ICD) to help manage your heart rhythm. It’s important to know that if you've had a successful VTA ablation in the past and have not had any issues since, you would not qualify for this study. Overall, this trial aims to improve care for patients like you by exploring new treatment options during LVAD surgery.

Gender

ALL

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