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
Treatment
Study Type
Interventional
Phase
Phase 4

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
23-5082
Category
Heart/Cardiovascular Diseases
Contact
Julie Sorg
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05034432
For detailed technical eligibility, visit ClinicalTrials.gov.