Key result
reBEAT soft-robotic MCS increases MAP by ~9 mmHg with no severe adverse events.
Why the study?
Mechanical circulatory support in advanced heart failure remains limited by blood-contact complications and the absence of biventricular support, motivating the first clinical evaluation of a novel external, non-blood-contacting soft-robotic biventricular pulsatile device.
Does a temporary soft-robotic biventricular mechanical circulatory support device placed externally without blood contact demonstrate short-term safety, feasibility, and improved haemodynamic performance in patients with end-stage heart failure?
Does a temporary soft-robotic biventricular mechanical circulatory support device placed externally without blood contact demonstrate short-term safety, feasibility, and improved haemodynamic performance in patients with end-stage heart failure?
Absolute Event Rate: 76.2% vs 67.5%
p-value: p=<0.01
This first-in-human prospective clinical trial demonstrates that a novel custom-fitted, external soft-robotic biventricular support device avoiding blood contact can be safely and rapidly implanted with significant short-term improvements in mean arterial pressure, stroke work, and cardiac power output.
Aims Mechanical Circulatory Support (MCS) remains limited in advanced heart failure due to blood-contact complications and the absence of biventricular support. We report the first prospective clinical trial of a novel soft-robotic, biventricular, pulsatile technology placed externally around the heart without blood contact, designed to deliver individualized cardiac assistance (reBEAT®, AdjuCor GmbH, Munich, Germany). Methods and Results The system was temporarily applied in 10 end-stage heart failure patients immediately before elective LVAD implantation. Devices were custom-manufactured using preoperative CT scans to match individual cardiac anatomy. Safety, feasibility, and effects on haemodynamics were evaluated. Implantation was rapid (3±2 min), demonstrating procedural feasibility. We observed two procedure-related adverse events while no device- or procedure-related severe adverse events occurred. Absence of new ECG abnormalities, and no tissue injury confirmed safety. An iterative assessment on haemodynamics provided key insights into individualized cardio-circulatory support. While device presence reduced preload dependent haemodynamics in some patients, low average support pressures of 65–66 mmHg produced variable improvements towards baseline, predominantly on the pressure signal: mean arterial pressure (MAP; 67.5 ± 10.6 vs. 76.2 ± 11.7 mmHg, p<0.01), stroke work (SW; 347.8 ± 118.2 vs. 434.1 ± 131.0 mJ, p<0.01), and cardiac power output (CPO; 407.9 ± 108.2 vs. 503.7 ± 116.2 mW, p<0.01). Additionally, effects were observed on atrioventricular valve function and interventricular balance, which were not significant. Conclusion This soft-robotic biventricular MCS platform provides short term evidence of a safe and feasible approach to pulsatile biventricular support without blood contact. Significant increases in MAP, CPO, and SW towards baseline indicate functional effects. Continuous device-driven workflow improvement is mandatory and further data are required to refine individualized optimization strategies. This technology may offer a novel biventricular assist modality. Its reduced complexity may enable broader adaption for both temporary and durable support. Avoiding blood contact and enabling balanced biventricular assistance will be central drivers of its continued clinical development.
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Ruhparwar et al. (2026) studied End-stage heart failure (n=10). reBEAT soft-robotic biventricular mechanical circulatory support device vs. No support (pre-support baseline/unassisted state) was evaluated on Safety, feasibility, and effects on haemodynamics (mean arterial pressure, stroke work, cardiac power output) (p=<0.01). The reBEAT soft-robotic biventricular MCS device was safely implanted in 3±2 min with 0 severe adverse events and significantly increased MAP (76.2 vs. 67.5 mmHg, p<0.01).
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