The study will evaluate the safety and efficacy of the Cordella pressure sensor system to treat heart failure
Digital health and medical technology firm Endotronix has recruited the first two patients in the PROACTIVE-HF pivotal trial of the Cordella pulmonary artery (PA) pressure sensor system.
The pre-market investigational device exempt (IDE) trial has been designed to assess the safety and efficacy of the Cordella pressure sensor system to treat chronic heart failure (HF).
The Cordella heart failure system delivers a comprehensive health status of the patient at home with advanced tools, which collect and share health data with healthcare providers for trend-based management. The Cordella Sensor incorporates PA pressure data into the Cordella system.
In the trial, the first two patients have been implanted with the Cordella Sensor by Dr Navin Kapur and Michael Kiernan at Tufts Medical Center in Boston of Massachusetts and Dr Liviu Klein at the University of California San Francisco (UCSF).
Endotronix will enrol over 950 patients in the multi-centre study
Endotronix will recruit more than 950 New York Heart Association (NYHA) Class III heart failure patients in the multi-centre, randomised, controlled trial single-blind trial at up to 60 sites across the US.
The dual-arm trial design compares HF management using daily patient vital sign data against daily vital sign plus PA pressure data.
Endotronix’s trial, which is designed to demonstrate a definitive benefit for PA pressure-guided management, includes protocolised PA pressure therapy guidelines and guideline-directed medical therapy (GDMT) for proactive HF management.
The PROACTIVE-HF trial’s primary endpoints comprise the reduction of HF hospitalisations and mortality.
The company will also use the data to support the US market access of the Cordella Sensor, as well as instruct a national coverage decision from the Centers for Medicare & Medicaid Services (CMS).
In 2019, the company secured Category B IDE Study approval from CMS to facilitate coverage and routine care services for the Cordella Sensor during the trial.
The Cordella Sensor is not yet available for commercial application in any part of the world. It is also under clinical assessment in Europe with the SIRONA II CE mark study. The Cordella system, without the sensor, is commercially available in the US and EU.
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.”
In October 2019, Endotronix announced the expansion of its Series D financing round, and procured a total of $70m funding in the round.