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

ConditionsArrythmiaCardiomyopathies
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intra-Op Prophylactic VT ablation

    Procedure/Surgery

    For surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and/or echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping

  • Conventional Management

    Other intervention

    To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intra-Op Prophylactic VT ablationExperimental treatment 1 intervention
Group B: Conventional ManagementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recurrent VTA

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

Time frame
Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)

Secondary outcomes

1

Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.

Number of participants with any of the following: hospitalization, stroke or right heart failure. Right heart failure assessed by Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) criteria.

Time frame
Post LVAD implant until end of follow-up, approximately 18 months
2

Mean duration of LVAD implant (and ablation) surgery

Time frame
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
3

Mean duration of ablation

Time frame
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
4

Mean rate of peri-procedural complication

Peri-procedural complications include bleeding, infection, and need for repeat operation.

Time frame
Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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