Open
Actively Recruiting
The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
About
Brief 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
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
Join this Trial
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Study Stats
Protocol No.
23-5082
Category
Heart/Cardiovascular Diseases
Principal Investigator
Contact
Location
- UCLA Westwood