US-based digital health and medical technology company Endotronix has enrolled first two patients in the PROACTIVE-HF pivotal trial, a pre-market investigational device-exempt (IDE) study evaluating the safety and efficacy of the Cordella Sensor.
Endotronix’s Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) is intended for the treatment of heart failure (HF).
The two patients enrolled in the trial were implanted with Cordella Sensor at Tufts Medical Center in Boston and at the University of California San Francisco (UCSF).
More than 950 New York Heart Association (NYHA) Class III heart failure patients are expected for enrolment on the prospective, multi-centre, randomised, controlled, single-blind trial.
The trials will be conducted at up to 60 sites across the US.
Dual-arm trial design will evaluate HF management using daily patient vital sign data as opposed to daily vital sign plus PA pressure data.
Endotronix CEO Harry Rowland said: “PROACTIVE-HF is a groundbreaking trial, designed to provide the highest level of clinical evidence in support of PA pressure-guided therapy.
“Our national coverage of top implanting centres positions us for successful study enrollment to further demonstrate that the Cordella Sensor and System provides efficient HF management, improves clinical outcomes and has the potential to redefine the standard of care for patients with chronic heart failure.”
The decrease in HF hospitalisations and mortality are the primary endpoints of this trial.
UCSF Mechanical Circulatory Support Program director Dr Liviu Klein is the principal investigator of the PROACTIVE-HF trial.
Cordella Sensor is also under clinical investigation in Europe for CE Mark approval. The Cordella, System, without the sensor, is allowed for commercial use in the US and Europe.