Endotronix has announced its PROACTIVE-HF pivotal study has successfully completed enrolment.
The study is designed to evaluate the safety and efficacy of the Cordella pulmonary artery (PA) sensor, and the resulting data will support the premarket approval (PMA) application for market access in the USA.
“Building upon a strong foundation of evidence in favour of PA pressure-guided therapy, the PROACTIVE-HF trial is investigating a more comprehensive clinical picture for both clinicians and patients,” commented Liviu Klein (University of California San Francisco, San Francisco, USA), national principal investigator of the PROACTIVE-HF trial. “Cordella provides daily PA pressure and vital sign data to help clarify patient’s clinical status. Additionally, we are seeing high levels of engagement and lifestyle changes as a result of patients having visibility to their own data. We look forward to sharing the study results in the coming months.”
Described by Endotronix as the first global investigational device exemption (IDE) study for PA pressure-guided heart failure management, PROACTIVE-HF enrolled over 450 patients across the USA, Ireland, and Belgium. Primary endpoints for the single-arm, multicentre trial include mortality and heart failure hospitalisations as well as device safety. The company expects to report primary endpoint data from the trial in the first half of 2024.
“I would like to congratulate all our clinical partners on their tremendous effort to complete enrollment for PROACTIVE-HF. Their hard work and dedication are key to improving outcomes and expanding patient access, and we appreciate their continued commitment to this trial,” stated Harry Rowland, CEO and co-founder of Endotronix.