Rethinking Early Clinical Trials: Design of the CorWave LVAD Feasibility Trial

Document Type

Conference Proceeding

Publication Date

4-1-2023

Publication Title

J Heart Lung Transplant

Abstract

Purpose: The CorWave LVAD uses a unique wave membrane technology for low shear blood propulsion, operating in a pulsatile mode, synchronized with the native ventricle. Preclinical testing suggests this new LVAD could overcome several limitations of continuous flow LVADs. The device will be evaluated in a multicenter feasibility study in Australia, Europe, and Asia. Patients, Clinicians, and Device Developers share a mutual interest to confirm device safety and performance as early as possible.

Methods: Up to 15 patients will be enrolled using typical LVAD inclusion/exclusion criteria: patients with worsening heart failure despite optimal medical management. As in other LVAD trials, the primary endpoint will be survival. Secondary endpoints include freedom from adverse events (AEs), (e.g. stroke, bleeding, infection, and pump replacement), quality of life and neurocognitive measures. Given that this is a feasibility study, not powered to demonstrate clinical benefit, we also plan to collect data predictive of AEs, validating preclinical data where applicable. These will include von Willebrand Factor assays, arterial pulse pressure and aortic valve opening, which are factors implicated in bleeding and aortic insufficiency. Increased aorta stiffness post-LVAD, correlated with increased AEs, will be measured. The synchronous, pulsatile flow of the CorWave LVAD is hypothesized to improve patient exercise capacity and possibly native ventricular recovery. Thus, patients will undergo exercise testing and evaluation of ventricular size and ejection fraction while on pump support.

Results: Potential outcomes include 1) Low AEs and favorable biomarker and functional test data, permitting judicious initiation of a pivotal trial, 2) Equivocal AEs and/or inconclusive biomarker and functional results, enabling Clinicians and Device Developers to collaborate to identify improvements prior to a pivotal trial, or 3) Increased AEs with negative biomarker and functional data, requiring device design and/or management revisions prior to re-commencing clinical studies.

Conclusion: Survival rates achieved with current LVADs create a challenging standard, but the high AE rates offer opportunities for new technologies to prevent stagnation in the field. New approaches to cost-effective early LVAD trial design are required to sustain innovation and safely transition into pivotal trials.

Volume

42

Issue

4

First Page

S340

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