February 18, 2020
First Patients Enrolled in the PROACTIVE-HF Pivotal Trial of Endotronix’s Cordella Sensor
February 18, 2020—Endotronix, Inc. announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a premarket investigational device exemption (IDE) study evaluating the safety and efficacy of the company’s Cordella pulmonary artery (PA) pressure sensor system for the treatment of chronic heart failure (HF). Data from this trial will support United States market access of the Cordella sensor and inform a national coverage decision from the Centers for Medicare & Medicaid Services (CMS).
In August 2019, the company announced that CMS granted approval for this Category B IDE study, which will allow coverage of the Cordella sensor and routine care services during the trial.
According to Endotronix, the prospective, multicenter, single-blind, randomized controlled trial is expected to enroll over 950 patients with New York Heart Association class III HF at up to 60 sites across the United States. The dual-arm trial is designed to compare HF management using daily patient vital sign data versus daily vital sign plus PA pressure data. The trial aims to show a definitive benefit for PA pressure–guided management.
The landmark trial incorporates protocolized PA pressure therapy guidelines and guideline-directed medical therapy for proactive HF management. Primary endpoints of the study include the reduction of HF hospitalizations and mortality.
The first two patients underwent successful implantation of the Cordella sensor by Navin Kapur, MD, and Michael Kiernan, MD, at Tufts Medical Center in Boston, Massachusetts and Liviu Klein, MD, at the University of California San Francisco (UCSF) in San Francisco, California.
Dr. Klein, who is Director of the Mechanical Circulatory Support Program at UCSF, serves as National Principal Investigator of the PROACTIVE-HF trial. In the company’s announcement, Dr. Klein commented, “Management of chronic heart failure patients can be challenging. The Cordella sensor and system provide a unique combination of daily patient PA pressure and vital sign data, enabling me and my team to make smarter, trend-based clinical decisions before decompensation ”
He continued, "Based on my early experience, the Cordella system offers an intuitive at-home patient experience, including a seated PA pressure reading, for remote management. I’m excited for the PROACTIVE-HF trial and look forward to clearly demonstrating the benefits of hemodynamic PA pressure—guided therapy and its impact on clinical outcomes.”
The Cordella sensor is not available for commercial use in any geography and is under clinical investigation in Europe (SIRONA 2 CE Mark trial) and the United States (PROACTIVE-HF IDE trial). The Cordella system, without the sensor, is available for commercial use in the United States and European Union and is currently in cardiology centers across the United States, advised Endotronix.