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

Phase 4

Recruiting

• Conditions: Arrythmia; Cardiomyopathies
• Interventions: Procedure: Intra-Op Prophylactic VT ablation; Other: Conventional Management

• Registration Number: NCT05034432
• Lead Sponsor: University of Rochester

Brief Summary

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.

Study Timeline

• Study First Submitted: 2021-08-29
• Study First Submitted QC: 2021-08-29
• Study First Posted: 2021-09-05
• Study Start: 2022-05-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-Op Prophylactic VT ablation	Intra-Op Prophylactic VT ablation	Subjects will get ablation procedure as needed if they were determined to be refractory to medical antiarrhythmic control should undergo catheter-based electrophysiology study and ablation on LVAD support
Conventional Management	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

Name	Time	Method
Recurrent VTA	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 Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by medical records for hospitalization, stroke and heart failure.	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.
Mean duration of LVAD implant (and ablation) surgery	Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean duration of ablation	Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)
Mean rate of peri-procedural complication	Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)	Peri-procedural complications include bleeding, infection, and need for repeat operation.
Mean Length of stay in the intensive care unit after LVAD implant	Admission for LVAD implant until hospital discharge (approximately 2-4 weeks)

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States