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NCT Number: NCT05034432

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

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

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Key information

Conditions

Arrythmia Arrhythmias, Cardiac Cardiomyopathies Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Banner University Medical Center, Phoenix, Arizona, United States

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About this study

This study is a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA who will be randomized in a 1:1 ratio to intra-operative VTA ablation vs. conventional medical management. Comprehensive data on arrhythmia history, medication history will be collected in all randomized subjects. Antiarrhythmic medical therapy will be handled in a uniform pattern between the two arms. Randomized subjects will then be followed per routine schedules for post LVAD implant. Arrhythmia data, ICD therapy, additional procedures including repeat surgery, ramp echocardiographic tests, right heart catheterization and catheter-based VTA ablation will be collected. In addition, adverse events such as unplanned hospitalizations, emergency department visits, clinic visits, and all other aspects of health care utilization will be gathered. The planned average follow-up period will be 18 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-Op Prophylactic VT ablation

Procedure

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

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

Primary outcomes

  1. Recurrent VTA

    Time frame: Post 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

Secondary outcomes

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

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

    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.

  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

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

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

  5. Mean Length of stay in the intensive care unit after LVAD implant

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Colasurdo

CONTACT

[email protected]

585-275-1054

Kathy Honsinger

CONTACT

585-273-1899

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)

Acronym: PIVATAL

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2021
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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