VT Ablation Before LVAD Surgery for Arrhythmia
(PIVATAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is VT ablation generally safe for humans?
How is the treatment Intra-Op Prophylactic VT ablation different from other treatments for arrhythmia?
Intra-Op Prophylactic VT ablation is unique because it is performed during the surgery to implant a left ventricular assist device (LVAD), targeting ventricular tachycardia (a type of fast heart rhythm) that may occur after the device is placed. This approach aims to prevent arrhythmias by addressing them directly during the LVAD surgery, which is different from other treatments that are typically done separately and after the device implantation.24678
What data supports the effectiveness of the treatment Intraoperative Ventricular Tachycardia Ablation for arrhythmia?
Research suggests that performing intraoperative ventricular tachycardia (VT) ablation during left ventricular assist device (LVAD) implantation may reduce the recurrence of VT and improve outcomes for patients with advanced heart failure. Additionally, case studies have shown that VT ablation can be effective in reducing VT episodes in patients with structural heart disease, potentially leading to better management of arrhythmias.25679
Who Is on the Research Team?
David Huang, MD
Principal Investigator
University of Rochester
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced heart muscle disease who are eligible for a heart pump device (LVAD) implant. They must have had or be getting a defibrillator due to past episodes of dangerous heart rhythms within the last 5 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo intra-operative VTA ablation or conventional medical management during LVAD implant
Follow-up
Participants are monitored for safety and effectiveness after treatment, including arrhythmia data and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Conventional Management
- Intra-Op Prophylactic VT ablation
Intra-Op Prophylactic VT ablation is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator