Sorin Group (MIL:SRN) announced today 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 unique 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 Resynchronization Therapy Defibrillators (CRT-D) in Europe and US.
According to the American Heart Association (AHA) and the European Society of Cardiology (ESC) Guidelines, heart failure currently affects about 5 million Americans and 15 million people in the 35 countries under the auspices of the ESC.
Heart failure is the most common Medicare diagnosis-related group (hospital discharge diagnosis), and more Medicare dollars are spent for the diagnosis and treatment of HF than for any other diagnosis. In Europe, HF accounts for about 2% of national expenditures on health.
As the severity of HF can fluctuate and drug therapies adjusted to improve the patient’s condition, it is important to monitor recognised indicators of disease progression to prevent the patient being hospitalized. 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 hospitalization.
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.