Haut-Lévêque Hospital
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.
