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

Official title

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

Overview

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

Detailed description

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.

Interventions

• Procedure Intra-Op Prophylactic VT ablation
  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 electroan
• Other Conventional Management
  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 outcome measures

• Recurrent VTA [Time frame: Post LVAD implant until end of follow-up, through study completion, an average of 18 months (minimum 6 months)]

Secondary outcome measures (5)

• 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]
• Mean duration of LVAD implant (and ablation) surgery [Time frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)]
• Mean duration of ablation [Time frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)]
• Mean rate of peri-procedural complication [Time frame: Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)]
• 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)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 19 centers

• Banner University Medical Center — Phoenix
• UCLA Cardiac Arrthmia Center — Los Angeles
• University of California San Francisco — San Francisco
• Medstar Washington Hospital Center — Washington D.C.
• Piedmont Heart Institute — Atlanta
• Emory University — Atlanta
• Ascension St. Vincent Indianapolis — Indianapolis
• Univedrsity of Louisville — Louisville
• … and 11 more centers

Publications

• Oates CP, Lam PH, Lawrence L, Bigham G, Meda NS, Basyal B, Hadadi CA, Rao SD, Hockstein M, Shah M, Sheikh FH. Early Ventricular Arrhythmias After Left Ventricular Assist Device Implantation. J Card Fail. 2024 Aug;30(8):1018-1027. doi: 10.1016/j.cardfail.2023.11.018. Epub 2023 Dec 15. PMID 38103723

Identifiers

NCT: NCT05034432 · STUDY00006159 · R01HL159401

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗