The study evaluates the use of Cordella in pulmonary artery (PA) pressure-guided therapy. PROACTIVE-HF 2, a prospective, dual-arm trial, aims to expand access for heart failure patients. Endotronix seeks to support efficient and scalable remote patient management with a clinician-directed self-management strategy.
According to a news release, the company expects to enroll up to 1,500 patients in the U.S. and Europe. It anticipates the first patient enrollment later this year.
PROACTIVE-HF 2’s randomized arm assesses the safety and efficacy of PA pressure-guided therapy using Cordella. That arm evaluates NYHA Class II patients at risk for congestion. In both cohorts, patients and clinicians can access daily trended telehealth data. The treatment cohort can also access daily PA pressure data.
More about the Endotronix study
Endotronix says its study evaluates the safety and efficacy, using composition-first heart failure event or death rate, for up to 24 months. The single-arm study assesses the impact of clinician-directed self-management. It uses a 12-month endpoint for safety and incidence of heart failure hospitalization or death.
Both arms intend to collect data on secondary endpoint, including changes in right ventricular function in relation to PA pressure. Endotronix said both arms also seek data on patient engagement.
The company also said it presented positive sub-study data from the initial pivotal PROACTIVE-HF trial. It demonstrated a low heart failure hospitalization rate of 0.34 at 12 months in NYHA Class III heart failure patients. Endotronix said it’s preparing data fro a premarket approval submission to the FDA by the end of the year.
“We are establishing a strong foundation of compelling clinical evidence for Cordella with early PROACTIVE-HF data,” Harry Rowland, CEO and co-founder said. “The team is driving towards PMA submission before the end of this year and looks forward to sharing the results from the full study cohort in 2024. We remain confident in the benefits Cordella brings to patients and clinicians to improve heart failure outcomes and remain on track for a mid-2024 launch.”
