Endotronix PROACTIVE-HF Pivotal Trial of Cordella Sensor Receives FDA Approval to Shift to Single-Arm Design

January 5, 2022—Endotronix, Inc. announced that the FDA has granted approval for a shift of the company’s PROACTIVE-HF investigational device exemption (IDE) trial design from a randomized controlled to a single-arm study.

The PROACTIVE-HF pivotal IDE trial is investigating Endotronix’s Cordella pulmonary artery (PA) pressure sensor, a next-generation wireless sensor that works as part of the Cordella heart failure system to provide key information on a patient’s daily health to proactively and remotely adjust therapy and medications, explained the company.

In the announcement, Endotronix noted that this approval follows a 2021 update to the 2017 American College of Cardiology Expert Consensus Decision Pathway for optimization of heart failure treatment (J Am Coll Cardiol. 2021;77:772-810) and the GUIDE-HF data (Lancet. 2021;398:991-1001), which have demonstrated the clinical benefits of PA pressure-guided heart failure management for New York Heart Association (NYHA) class III heart failure patients.

Liviu Klein, MD, National Principal Investigator of PROACTIVE-HF, provided context for the design change, “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.”

Dr. Klein continued, “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 heart failure 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.” Dr. Klein is Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at University of California San Francisco.

With the change to a single-arm design, the company noted that the > 100 enrolled patients will have immediate access to PA pressure-guided therapy. The study has also expanded to include clinical sites across Europe and the United States.

The single-arm study design has similar safety and efficacy endpoints as the original design, with a primary efficacy endpoint of low all-cause mortality and heart failures hospitalization rates in NYHA class III patients. More than 400 patients at > 100 sites worldwide will be included, and enrollment is expected to be completed in the second half of 2022.

“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 acknowledgment for the therapeutic category and the benefits that PA pressure-guided heart failure management enables,” noted Harry Rowland, Chief Executive Officer of Endotronix.

The Cordella system without the sensor is available for commercial use in the United States and European Union, and the Cordella PA sensor is under clinical investigation in Europe and the United States and not yet available for commercial use.