Endotronix Cordella PA Sensor System Evaluated at 1 Year in PROACTIVE-HF

October 3, 2024—Endotronix, an Edwards Lifesciences company, announced 1-year clinical results from the PROACTIVE-HF trial evaluating outcomes with the Cordella pulmonary artery (PA) sensor system.

According to the company, the data demonstrated that the 456 patients managed with the Cordella device in the study experienced a meaningful reduction in 1-year heart failure (HF) hospitalization and all-cause mortality, with 36 events per 100 patients versus 70 events per 100 patients that were prespecified (49% lower).

The study’s secondary endpoints of quality of life and biomarker reduction also showed the following significant improvements:

• 10.5% in Kansas City Cardiomyopathy Questionnaire (5.7 points)
• 13.3% in 6-minute walk test (35 meters)
• 36.2% in New York Heart Association classification (165 patients)
• 5.7% reduction in N-terminal pro–B-type natriuretic peptide levels (168 points)

The company stated that the safety and efficacy results at 12 months further validate the 6-month data that were published online in August 2024 by Jason L. Guichard MD, et al in JACC: Heart Failure and presented in March at THT 2024, the Cardiovascular Research Foundation’s Technology and Heart Failure Therapeutics conference.

The 12-month data were shared as part of the Heart Failure Society of America annual scientific meeting, which was scheduled to take place September 27-30 in Atlanta, Georgia, but canceled in anticipation of Hurricane Helene.

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

“These data are consistent and compelling, validating that PA pressure-guided therapy improves heart failure outcomes,” commented Dr. Klein in the company’s press release. “The trial results add to the growing understanding of the impact of comprehensive data—seated PA pressure and vital signs—to further improve outcomes, inform remote medical adjustments, and directly engage heart failure patients in their own care.”

Dr. Klein continued, “In the trial, clinicians reduced the PA pressures of congested patients by optimizing guideline-directed medical therapy and diuretics to improve heart function. And unique to Cordella, patients have visibility to their health data that helps drive their engagement and compliance.”