NCT05577195

Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO

UNLOAD ECMO - Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO - a Prospective, Randomized, Controlled, Multi-center Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, randomized (1:1), controlled trial of Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation vs. veno-arterial extracorporeal membrane oxygenation alone for the treatment of cardiogenic shock.

Detailed description

In the past years extensive efforts in developing treatment strategies for patients with cardiogenic shock have been performed. One promising such strategy is active unloading of the left ventricle while simultaneously supporting the circulatory system with veno-arterial extracorporeal membrane oxygenation. Recently, in a multinational, multicenter, retrospective registry, it has been shown that this approach might be associated with lower mortality . The investigators now seek to extend the evidence on this topic and to test this approach in a prospective, randomized, controlled, multicenter trial. A power calculation has been conducted based on the data from the registry. N=198 patients with cardiogenic shock will be randomized 1:1 to be either treated with an Impella for active left ventricular unloading on top of veno-arterial extracorporeal membrane oxygenation or with veno-arterial extracorporeal membrane oxygenation alone. A blinded interim analysis will be performed, which might lead to an adjustment of the enrollment target. The primary endpoint of this study will be death from any cause 30 days after randomization.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	Impella	To provide active left ventricular unloading in the experimental arm
DEVICE	VA-ECMO	To provide circulatory support in both arms

Timeline

• Start date: 2022-11-17
• Primary completion: 2024-11-30
• Completion: 2025-12-01
• First posted: 2022-10-13
• Last updated: 2022-12-29

Locations

1 site across 1 country: Germany