The study investigates the sensitivity to changes in heart failure status of PhD
Sorin Group has reported the first inclusion of a patient in the Clepsydra clinical trial. The study will investigate the sensitivity to changes in heart failure status of PhD, a diagnostic feature using the dual sensor technology of minute ventilation and accelerometer to monitor patient’s breathing and activity levels every day. The algorithm aims to provide physicians with both trends and indicators in order to highlight sustained changes in overall health status that could relate to heart failure (HF) evolution.
PhD is available in the Paradym family of implantable cardioverter defibrillators (ICD) in Europe and under clinical evaluation in implantable cardiac resynchronisation therapy defibrillators (CRT-D) in Europe and US.
PhD measures activity workload and ventilation at rest and exercise, which are two key measurements to indicate that a patient’s heart failure condition is progressing.
The Clepsydra study will test the PhD algorithm that is designed to give advance notice of sustained deterioration. Advanced warning at follow-up could give physicians time to intervene in the patient’s treatment to avoid the costs and patient burden associated with hospitalisation.
The Clepsydra study, will evaluate PhD in 550 patients to be enrolled in the US and Europe. Patients will be closely monitored over a minimum of 13 months by hospital visits and by telephone checks.
Stefano Di Lullo, president of Sorin Group Cardiac Rhythm Management (CRM) Business Unit, said: “Monitoring of the patient physiological status (PhD) is a step to giving physicians an accurate guide to optimising heart failure therapy and avoid costly hospitalisations. The Clepsydra study highlights Sorin Group’s commitment to backing our leading technologies with large scale clinical justification.”