Endotronix has announced data from the SIRONA 2 clinical trial evaluating safety and efficacy of its Cordella pulmonary artery pressure sensor system in New York Heart Association (NYHA) class III heart failure patients.
The prospective, multicentre trial met all primary safety and efficacy endpoints and resulted in low rates of HF hospitalisation, further validating pulmonary artery (PA) pressure-guided HF management as standard of care for NYHA class III heart failure patients. Data from the SIRONA 2 trial was presented in a late-breaking session at European Society of Cardiology’s (ESC) Heart Failure Association (HFA) 2022 annual conference (22 May; Madrid, Spain).
”In addition to achieving the primary safety and accuracy endpoints, the SIRONA 2 trial demonstrated a consistently high level of patient compliance with daily readings of PA pressure and physiologic data with a strong preference for performing PA pressure measurements from a seated position,” stated Wilfried Mullens (Hospital Oost-Limburg, University Hasselt, Genk, Belgium). “The daily measurements provided a comprehensive clinical picture of the patient’s health over time which supported guideline directed medical therapy (GDMT) resulting in excellent clinical outcomes with low heart failure hospitalisation (HFH) rates.”
The open-label, single-arm SIRONA 2 trial included 70 patients who were successfully implanted with the Cordella Sensor at seven European sites across Ireland, Belgium and Germany. The results confirmed a strong safety profile with no PA sensor failures, only one device/system related complication (DSRC=1.3%) and 0% mortality at 90 days.
The primary efficacy endpoint of accuracy, comparing Cordella Sensor with the gold standard fluid-filled reference catheter accuracy at 90 days, was also met. In addition, the study demonstrated a low six-month HF hospitalisation event rate (0.16) with the majority of patients improving their NYHA classification (67.5%). Compliance with daily readings of PA pressure, weight, blood pressure, heart rate and blood oxygen were consistently above 93% over six months. Moreover, patients overwhelmingly found the system easy to use (94%) and were knowledgeable about their normal range of daily measurements (67%).
PROACTIVE-HF is the first global IDE study for PA pressure-guided heart failure management and is currently enrolling patients to further validate the clinical findings from SIRONA 2.