Endotronix has announced that the US Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal Investigational Device Exemption (IDE) trial investigating the Cordella Pulmonary Artery (PA) Pressure Sensor, shifting the design from a randomised control study to a single-arm study.
Following the 2021 update to the 2017 American College of Cardiology (ACC) Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment and the recently presented GUIDE-HF data, the FDA’s decision underscores the clinical benefits of PA pressure-guided HF management for New York Heart Association (NYHA) class III heart failure patients, Endotronix said in a press release.
“The FDA’s decision to approve the amended study design further validates what we are seeing in clinical practice. PA pressure-guided heart failure management is quickly becoming standard of care for NYHA class III patients based on the growing body of evidence supporting this approach,” commented Liviu Klein (University of California San Francisco, San Francisco, USA) and national principal investigator of the PROACTIVE-HF trial. “Understanding changes in PA pressure data is key to properly implementing guideline directed medical therapy and keeping these patients out of the hospital. The Cordella HF System and Sensor offers the next gen technology in PA pressure sensing and will play a critical part in how heart failure patients are managed moving forward.”
The single-arm study design maintains similar safety and efficacy endpoints as the original study design, with the primary efficacy endpoint designed to demonstrate low rates of all-cause mortality and HF hospitalisations in the high-risk NYHA class III patient cohort.
Under the updated study design, the PROACTIVE-HF trial will enrol over 400 NYHA class III patients at more than 100 sites worldwide. The trial is expected to complete enrolment in the second half of this year.
“The FDA’s decision is great news for our PROACTIVE-HF study patients—they now have immediate access to technology that is designed to keep them healthier and out of the hospital. Furthermore, it is an important acknowledgement for the therapeutic category and the benefits that PA pressure-guided heart failure management enables,” stated Harry Rowland, CEO of Endotronix. “Our team and clinical partners have been energised by the announcement and it obviously has a significant impact on our ability to bring the Cordella Sensor to market sooner in the US and Europe.”