Digital health and medical technology company Endotronix has concluded the enrolment of patients for a trial to evaluate the safety and efficacy of the Cordellapulmonary artery (PA) sensor system.
Dubbed the PROACTIVE-HF, the pivotal trial is claimed to be the first global investigational device exemption (IDE) study for PA pressure-guided heart failure (HF) management.
The company recruited more than 450 patients across the US, Ireland and Belgium for the PROACTIVE-HF, which is an open-label, single-arm, multi-centre clinical trial.
Mortality, HF hospitalisations, and device safety are the primary endpoints of the study.
Primary endpoint data from the study is expected to be reported in the first half of next year.
Endotronix will use the data from the trial to support its pre-market approval (PMA) application for the device in the US.
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Endotronix CEO and co-founder Harry Rowland said: “I would like to congratulate all our clinical partners on their tremendous effort to complete enrollment for PROACTIVE-HF.
“Their hard work and dedication are key to improving outcomes and expanding patient access, and we appreciate their continued commitment to this trial.”
The Cordella system is designed to measure, record and transfer data related to pulmonary artery pressure (PAP) from the patient’s home to clinicians for evaluation and proactive, patient-centred remote HF management.
Comprising seven subsystems, the system takes daily PAP readings at a patient’s home and transfers the data to a care provider for assessment.
The subsystems include Cordella Sensor, Cordella Delivery System, myCordella Patient Reader, Reader Dock, Cordella Calibration Equipment (CalEQ), myCordella hub and Cordella Data Analysis Platform (CDAP).