Location: Pessac, Bordeaux Area (CHU de Bordeaux)

Focus Area: Advanced Electrophysiology and Heart Failure Management.

Study Protocol

The clinical trial at Haut-Lévêque Hospital represents a critical phase in validating the Medrik Ring for long-term ambulatory monitoring. This facility, renowned for its cardiology and electrophysiology departments, provides the ideal environment to test the ring’s sensitivity in detecting subtle rhythm anomalies.

Patient Cohort

• Sample Size: 50 patients aged 18-85.
• Inclusion: Patients with paroxysmal atrial fibrillation or frequent premature ventricular contractions (PVCs).
• Exclusion: Patients with implantable cardioverter-defibrillators (ICDs) to prevent signal interference.

Primary Endpoints

• Arrhythmia Detection Accuracy: Comparison of event detection rates (Sensitivity/Specificity) against a synchronized 12-lead Holter monitor over 48 hours.
• Motion Artifact Rejection: Assessing the proprietary AI algorithm’s ability to filter out noise during walking, running, and daily activities.

Current Status

The study is currently active. Preliminary data suggests a 98% correlation in heart rate variability (HRV) metrics compared to gold-standard ECG, with patients reporting significantly higher satisfaction with the ring form factor versus adhesive patches.

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.

Location: Bordeaux (University Hospital)

Focus: Emergency and Post-Operative Recovery (Cardiac Surgery).

Overview

The clinical trial at Hospital Pellegrin targets one of the most critical windows in patient care: the immediate post-operative period following cardiac surgery (e.g., valve replacement, CABG). This study investigates the « Bridge to Home » concept, aiming to safely reduce hospital stays through continuous remote surveillance.

Study Objectives

• Early Decompensation Warning: To determine if the Medrik Ring can identify early signs of hemodynamic instability (such as dropping stroke volume) 24-48 hours before clinical symptoms appear.
• Readmission Reduction: The primary goal is to reduce the 30-day readmission rate by 20% by enabling timely interventions before a patient requires emergency hospitalization.

Methodology

Patients are fitted with the Medrik Ring upon discharge from the ICU. Their hemodynamic trends are monitored remotely for 30 days. Any significant deviation triggers an alert for the on-call cardiology team to review the data and contact the patient.

Current Status

Recruiting phase. This study is pivotal for demonstrating the economic value of the Medrik platform to healthcare payers and insurance systems, potentially saving thousands of Euros per patient in avoided readmission costs.