Rationale and design of the randomized ‘early ventricular assist device’—Trial (VAD-DZHK3)

Abstract

Aims

Bridge to transplantation (BTT) with durable, continuous-flow left ventricular assist devices (LVAD) of patients is a well-established treatment concept in patients awaiting heart transplantation (HTx). However, the role of elective LVAD implantation in patients with less advanced HF, but increased risk of decompensation remains uncertain.

Methods and results

The VAD-DZHK3 trial is an investigator-initiated, randomized controlled trial designed to assess whether an early strategy of elective LVAD implantation improves outcomes compared with a conventional approach involving optimal medical therapy and delayed device implantation only after clinical deterioration. Eligible patients are those with end-stage HF listed for cardiac transplantation. This is an event-driven study, that is, the study is completed once 120 events of the primary composite endpoint have been observed and all patients have at least 1 year of follow-up unless they died earlier. Patients meeting inclusion criteria who decline randomization are enrolled in a parallel observational registry reflecting standard care. The primary efficacy endpoint is survival free from high urgent cardiac transplantation, disabling stroke and HF hospitalizations (including emergency room HF visits >6 h).

Conclusions

The VAD-DZHK3 trial will provide guidance on the optimal timing and patient selection for LVAD implantation in heart transplant candidates, potentially redefining current standards of care.