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

Cardiomyopathies Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Cardiomyopathies

• NCT number: NCT05034432
• Study type: Interventional
• Source: University of Rochester
• Contact: Ann Colasurdo
• Phone: 585-275-1054
• Email: ann_colasurdo@urmc.rochester.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: May 27, 2022
• Completion date: June 30, 2026