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The PIVATAL Study: Ventricular Arrhythmia Ablation in LVAD Patients

This study, called The PIVATAL Study, is looking at whether a procedure called intra-operative VTA ablation (a surgery to treat abnormal heart rhythms) can reduce the number of abnormal heart rhythms (ventricular arrhythmias or VTA) in people who are getting a left ventricular assist device (LVAD) implant. You might be able to join if you are over 18, have advanced cardiomyopathy (a heart muscle disease), are eligible for an LVAD, and have an implanted cardioverter defibrillator (ICD) or plan to get one. The study compares the VTA ablation procedure to conventional medical management, which includes antiarrhythmic drugs like amiodarone, sotalol, or dofetilide. The main goal is to see if the ablation reduces recurrent VTA after your LVAD implant. The current status of the study is unclear, and it plans to enroll 100 participants.

Study design
This is a randomized controlled trial, meaning participants are randomly assigned to one of two groups: intra-operative VTA ablation or conventional medical management. It is an open-label study, so both you and your doctors will know which treatment you are receiving, and it plans to enroll 100 participants.
What's involved
You will be followed per routine schedules after your LVAD implant, with data collected on your heart rhythm, ICD therapy, and other medical events. The planned average follow-up period is 18 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for an average of 18 months (with a minimum of 6 months) after their LVAD implant to track recurrent ventricular arrhythmias.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05034432

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Rochester
~100 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Intra-Op Prophylactic VT ablationConventional Management

At a glance

Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrent VTA
Measured over Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)

Conditions

Arrythmia
Cardiomyopathies

Explore related trials

ArrhythmiaCardiomyopathy

Where it's being run

19 sites across 15 states
California2
Georgia2
New York2
Pennsylvania2
Arizona1
District of Columbia1
Indiana1
Kentucky1

Study leadership

  • David Huang, MD · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Ann Colasurdo
[email protected]
585-275-1054
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Recurrent VTAPost LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)

    Total VTA events, after accounting for the competing risk of death