Clinique Saint-Augustin
Location : Bordeaux
Lead Investigators : Dr. Eric Abergel & Dr. Stéphane Garrigue
Study Protocol
This pivotal validation study was designed to prove the core innovation of Medrik Technology: the ability to generate hemodynamic data non-invasively. Unlike standard fitness trackers that only measure heart rate, this study focused on complex volumetric metrics usually reserved for the catheter lab.
Primary Endpoints
- Virtual Catheter Verification : The study compared the AI-generated Pressure-Volume (P-V) loops from the Medrik Ring directly against data captured simultaneously by hospital-grade 3D Echocardiography (GE Vivid E95).
- Volumetric Accuracy : Assessing the error margin for Stroke Volume (SV) and Left Ventricular End-Diastolic Volume (LVEDV).
Key Findings
- Perfect Correlation : As highlighted in our « Analysis & Results » section, the Left Ventricular (LV) volume curves derived from the ring’s PPG signal showed a statistical correlation of r > 0.92 with the ultrasound ground truth.
- Clinical Utility : The results confirmed that the ring can accurately estimate Ejection Fraction within +/- 3% of the echocardiogram reading.
Impact
The success of this trial at Saint-Augustin serves as the foundational proof for our FDA benchmark comparisons and ongoing reimbursement strategy with health insurance providers.
