Six-month results from the PROACTIVE-HF pivotal trial, evaluating the Cordella pulmonary artery (PA) sensor (Endotronix) in New York Heart Association (NYHA) class III heart failure (HF) patients at risk of congestion, show that the trial met primary safety and efficacy endpoints.
The results demonstrated a low rate of HF hospitalisations in addition to showing a clinically significant improvement in patient quality of life, increased physical activity, and improvement in the NYHA functional class, Endotronix said in a press release.
The company previously announced the submission of its premarket approval application, which included the trial results. Liviu Klein (University of California, San Francisco, USA) presented the results during a late-breaking session at the Technology and Heart Failure Therapeutics (THT) conference (4–6 March, Boston, USA).
“These results are very encouraging and provide strong evidence in favour of HF management using PA pressure-guided therapy, along with vital sign data, to remotely optimise guideline-directed medical therapy and improve heart failure outcomes,” stated Klein, the national principal investigator of the PROACTIVE-HF trial. “Cordella offers a novel patient-friendly system that includes a handheld PA pressure reader and allows patient visibility to health data. In my opinion, these key differentiators helped drive high levels of engagement for patients and supported them to make healthy lifestyle choices. Combined with the clinicians’ targeted medication adjustments using the system’s comprehensive view of patient health status, we achieved great patient outcomes overall and when compared to the same period before sensor implant.”
The multicentre, prospective trial implanted 528 NYHA class III HF patients across 75 US and European sites. Over half of the implanters were heart failure specialists and the trial showed high rates of patient compliance (>6 avg Cordella submissions/week) and clinician engagement (>2 avg reviews/week). The six-month single-arm results met primary safety and efficacy endpoints as well as several clinically significant secondary efficacy endpoints.
“These results are the culmination of many years of hard work and dedication by the Endotronix team and our clinical partners as we strive to provide best-in-class care for heart failure patients,” commented Harry Rowland, CEO and co-founder of Endotronix. “We believe proactive, comprehensive care with Cordella improves the lives of patients living with heart failure and PROACTIVE-HF provides compelling evidence to support this new approach to impactful remote care delivery. With commercial launch expected later this year, we look forward to supporting clinicians in helping heart failure patients lead more full and active lives.”
