20: Clinical Investigation on the “Synchronized Cardiac Support” Treatment in Patients with Cardiogenic Shock – Rational and Design

Background/Introduction: Cardiogenic shock (CS) is a severe heart failure causing critical organ hypoperfusion. Veno-arterial ECMO (VA-ECMO) can be lifesaving but may increase left ventricular afterload and pulmonary congestion, often requiring additional unloading devices. Synchronized Cardiac Support (SCS) has been proposed as a novel treatment approach for patients with CS and need for VA-ECMO. During SCS, the pulsatile blood flow is synchronized via Electrocardiogram (ECG) with the patient’s cardiac cycle, aiming at diastolic augmentation and improving microcirculation through enhanced diastolic flow and reduced cardiac afterload by reducing blood flow during cardiac systole. This study aims to evaluate the efficacy and safety of the SCS treatment using the Novalung ultimate kit SCS in combination with Xenios 2.0 console (Xenios AG, Germany) in patients with CS due to Acute myocardial infarction (AMI). Methods: This prospective, multi-centre PMCF study will be conducted in four sites in Germany, the Czech Republic, and Spain, enrolling ca. 25 patients. Upon inclusion, patients will receive SCS treatment for up to 7 days. Cardiac performance will be assessed daily by Echocardiography and Pulmonary Artery Catheter (PAC) measurements in both, SCS and continuous flow conditions. Laboratory parameters (e.g. lactate) will serve as surrogate for organ perfusion and oxygen delivery. The study protocol is subject to final regulatory and ethical approval. Results: The study is scheduled to start 2026, results are planned to be published end 2027. Conclusion: This study aims to extend knowledge on SCS treatment in patients suffering from CS due to AMI. Moreover, the results will also help to understand whether ECG-triggered pulsatile blood flow may improve organ perfusion and may be capable of improving cardiac performance when compared to continuous flow ECMO, thus reducing the need to add unloading or venting devices in at least selected patients.