Endotronix has announced the enrolment of the first two patients in the PROACTIVE-HF trial. The trial is a premarket investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella pulmonary artery pressure sensor system (Cordella sensor) for the treatment of heart failure. The first two patients were successfully implanted with the Cordella Sensor by Navin Kapur and Michael Kiernan (both Tufts Medical Center, Boston, USA) and Liviu Klein (University of California San Francisco, San Francisco, USA).
The prospective, multicentre, randomised, controlled, single-blind trial is expected to enrol over 950 New York Heart Association (NYHA) Class III heart failure patients at up to 60 sites across the USA. The dual-arm trial design compares heart failure management using daily patient vital sign data versus daily vital sign plus pulmonary artery pressure data. Designed to show a definitive benefit for pulmonary artery pressure-guided management, the trial incorporates protocolised pulmonary artery pressure therapy guidelines and guideline-directed medical therapy for proactive heart failure management. Primary endpoints of the study include the reduction of heart failure hospitalisations and mortality. Additionally, the data from this trial will support US market access of the Cordella sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS). Endotronix also announced that last year they received Category B IDE Study approval from CMS, which will allow coverage of the Cordella sensor and routine care services during the trial.
Klein, national principal investigator of the PROACTIVE-HF trial, says: “Based on my early experience, the Cordella system offers an intuitive at-home patient experience, including a seated pulmonary artery pressure reading, for remote management. I am excited for the PROACTIVE-HF trial and look forward to clearly demonstrating the benefits of hemodynamic pulmonary artery pressure guided therapy and its impact on clinical outcomes.”
The Cordella sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA II CE mark trial) and the USA (PROACTIVE-HF IDE Trial).