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

Area of Science:

• Cardiology
• Medical Devices
• Clinical Trials

Background:

• Bridge to transplantation (BTT) using left ventricular assist devices (LVADs) is established for advanced heart failure (HF) patients awaiting heart transplantation (HTx).
• The optimal timing for elective LVAD implantation in patients with less advanced HF but a high risk of decompensation remains unclear.

Purpose of the Study:

• To assess if an early strategy of elective LVAD implantation improves outcomes compared to conventional therapy with delayed implantation.
• To provide guidance on optimal timing and patient selection for LVAD implantation in heart transplant candidates.

Main Methods:

• The VAD-DZHK3 trial is a randomized controlled trial comparing early elective LVAD implantation with optimal medical therapy and delayed LVAD implantation.
• The study is event-driven, focusing on 120 primary composite endpoint events and a minimum 1-year follow-up.
• The primary endpoint is survival free from urgent cardiac transplantation, disabling stroke, and HF hospitalizations.

Main Results:

• The VAD-DZHK3 trial is ongoing and results are pending.
• The study design allows for comparison of early vs. delayed LVAD implantation strategies.

Conclusions:

• The VAD-DZHK3 trial is expected to inform optimal timing and patient selection for LVADs in HTx candidates.
• Findings may redefine current standards of care for advanced HF management.