Sorin Group, a manufacturer of medical technologies for cardiac surgeries, has enrolled first patients in its Dream clinical trial.
The European longitudinal, multi-center, non-randomized trial is designed to assess sensitivity and positive predictive value of sleep apnea monitoring (SAM) in patients implanted by new REPLY 200 pacemaker.
SAM is designed to screen and monitor sleep apnea syndrome in bradyarrhythmia patients using sensors embedded in the implanted device.
France University Hospital principal study investigator Pascal Defaye said, "Because sleep apnea increases the risk of hypertension and cardiovascular diseases, being able to screen and monitor this syndrome with a new pacemaker feature will, I believe, help improve our patients' condition in the long run."
