Endotronix PROACTIVE-HF Pivotal Trial Completes Enrollment

April 4, 2023—Endotronix, Inc. announced completion of enrollment in its PROACTIVE-HF pivotal study, which is designed to evaluate the safety and efficacy of the company’s Cordella pulmonary artery (PA) sensor in the treatment of patients with heart failure (HF). The trial’s data will support the premarket approval application for the Cordella sensor for market access in the United States.

PROACTIVE-HF is a global investigational device exemption study for PA pressure–guided HF management. The trial enrolled > 450 patients across the United States, Ireland, and Belgium. Primary endpoints for the single-arm, multicenter trial include mortality and HF hospitalizations, as well as device safety. The company expects to report primary endpoint data from the trial in the first half of 2024.

The National Principal Investigator of the PROACTIVE-HF trial is Liviu Klein, MD. Dr. Klein is Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco in San Francisco, California.

“Building upon a strong foundation of evidence in favor of PA pressure–guided therapy, the PROACTIVE-HF trial is investigating a more comprehensive clinical picture for both clinicians and patients,” commented Dr. Klein in the company’s press release. “Cordella provides daily PA pressure and vital sign data to help clarify the 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.”

According to Endotronix, the Cordella HF system is a patient health management platform that combines comprehensive vital sign data from noninvasive devices to support patient-clinician engagement and care decisions. The solution is designed to enable proactive, data-driven HF management that engages patients, reduces and prevents congestion, and improves outcomes. The implantable PA pressure sensor directly measures the leading indicator of congestion, allowing early, targeted therapy, stated the company.

The Cordella PA pressure sensor system is an investigational device and is not currently approved for clinical use in any geography. In the United States, it is limited by federal law to investigational use.

The Cordella HF system without the sensor is available for commercial use in the United States and European Union, advised Endotronix.