NCT05034432 The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients
| NCT ID | NCT05034432 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Rochester |
| Condition | Arrythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-05-27 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-05-27 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
David Huang, MD
PRINCIPAL INVESTIGATOR
University of Rochester
Frequently Asked Questions
Who can join the NCT05034432 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arrythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05034432 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05034432 currently recruiting?
Yes, NCT05034432 is actively recruiting participants. Contact the research team at ann_colasurdo@urmc.rochester.edu for enrollment information.
Where is the NCT05034432 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, San Francisco, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT05034432 clinical trial?
NCT05034432 is sponsored by University of Rochester. The principal investigator is David Huang, MD at University of Rochester. The trial plans to enroll 100 participants.