Rationale and design of the randomized 'early ventricular assist device'-Trial (VAD-DZHK3)
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Date
2025-10
Publication Type
Journal Article
ETH Bibliography
yes
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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.
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published
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Book title
Journal / series
Volume
12 (5)
Pages / Article No.
3731 - 3740
Publisher
Wiley
Event
Edition / version
Methods
Software
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Date collected
Date created
Subject
Heart failure; Heart transplantation; Left ventricular assist device; Mechanical circulatory support
Organisational unit
Notes
For the VAD-DZHK3 Investigators