Seated pulmonary artery pressure management in patients with heart failure: 12-month outcomes of the PROACTIVE-HF trial
Authors
Jason L. Guichard, Department of Medicine, Division of Cardiology, Section for Advanced Heart Failure, Pulmonary Hypertension, and Mechanical Circulatory Support, Prisma Health-Upstate, Greenville, South Carolina, USA.
Eric L. Bonno, Department of Medicine, Division of Cardiology, Section for Advanced Heart Failure, Pulmonary Hypertension, and Mechanical Circulatory Support, Prisma Health-Upstate, Greenville, South Carolina, USA.
Michael E. Nassif, Saint Luke's Mid-American Heart Institute, Kansas City, Missouri, USA.
Taiyeb M. Khumri, Saint Luke's Mid-American Heart Institute, Kansas City, Missouri, USA.
David Miranda, Department of Cardiology, Minneapolis Heart Institute, Minneapolis, Minnesota, USA.
Orvar Jonsson, Department of Cardiology, North Central Heart and Avera Heart Hospital, Sioux Falls, South Dakota, USA.
Hirak Shah, Department of Cardiology, University of Kansas Medical Center, Kansas City, Kansas, USA.
Tamas Alexy, Department of Cardiology, University of Minnesota Medical Center, Minneapolis, Minnesota, USA.
Gregory P. Macaluso, Advocate Health - MidwestFollow
James Sur, Advocate Health - MidwestFollow
Gavin Hickey, Department of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
Patrick McCann, Department of Cardiology, Prisma Health, Columbia, South Carolina, USA.
Jennifer A. Cowger, Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan, USA.
Amit Badiye, Department of Cardiology, Sentara Healthcare, Norfolk, Virginia, USA.
Wayne D. Old, Department of Cardiology, Sentara Healthcare, Norfolk, Virginia, USA.
Yasmin Raza, Department of Cardiology, Northwestern, Chicago, Illinois, USA.
Luke Masha, Department of Cardiology, Oregon Health and Science University, Portland, Oregon, USA.
Chandra Kunavarapu, Department of Cardiology, Methodist Healthcare, San Antonio, Texas, USA.
Mosi Bennett, Department of Cardiology, Minneapolis Heart Institute, Minneapolis, Minnesota, USA.
Faisal Sharif, Department of Cardiology, Galway University Hospital, Saolta Group, CURAM and University of Galway, Galway, Ireland.
Michael Kiernan, Cardiovascular Center, Division of Cardiology, Tufts Medical Center, Boston, Massachusetts, USA.
Wilfried Mullens, Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Hasselt University, Hasselt, Belgium.
Sandra V. Chaparro, Miami Cardiac and Vascular Institute, Division of Cardiology, Baptist Health South Florida, Miami, Florida, USA.
Claudius Mahr, Institute for Advanced Cardiac Care, Medical City, Dallas, Texas, USA.
Rohit R. Amin, Department of Cardiology, Ascension Sacred Heart Hospital, Pensacola, Florida, USA.
Nicholas J. Hiivala, Clinical Science, Endotronix Inc, Naperville, Illinois, USA.
Max M. Owens, Clinical Science, Endotronix Inc, Naperville, Illinois, USA.
Andrea Sauerland, Clinical Science, Endotronix Inc, Naperville, Illinois, USA.
Omid Forouzan, Clinical Science, Endotronix Inc, Naperville, Illinois, USA.
Liviu Klein, Advanced Heart Failure Comprehensive Care Center and Division of Cardiology, University of California-San Francisco, San Francisco, California, USA. Electronic address: Liviu.Klein@ucsf.edu.
Recommended Citation
Guichard JL, Bonno EL, Nassif ME, et al. Seated Pulmonary Artery Pressure Management in Patients With Heart Failure: 12-Month Outcomes of the PROACTIVE-HF Trial. JACC Heart Fail. Published online February 12, 2026. doi:10.1016/j.jchf.2025.102847
Abstract
Background: In the PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients) trial, remote heart failure (HF) management using seated mean pulmonary artery pressure (mPAP) and vital signs was safe and resulted in a low rate of HF hospitalizations and mortality through 6 months.
Objectives: The authors evaluated the effect of managing seated mPAP with the Cordella system on outcomes in patients with HF through 12 months.
Methods: In a single-arm, open-label trial, conducted in 75 European and U.S. centers, the authors enrolled HF patients with NYHA functional class III symptoms, irrespective of ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The prespecified, powered, secondary effectiveness endpoint at 12 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.70 events/patient/12 months, established from previous hemodynamic monitoring trials. Device/system-related complications, pressure sensor failure, and serious adverse events were examined.
Results: Between February 7, 2020, and March 31, 2023, 456 patients were implanted in a modified intent-to-treat cohort. The 12-month event rate was 0.36 (95% CI: 0.31-0.42), which was significantly lower than the performance goal (0.36 vs 0.70; P < 0.0001). There were no device/system-related complications or pressure sensor failures beyond the 6-month primary results (0.8% and 0.2%, respectively).
Conclusions: Remote HF management using seated mPAP and vital signs in NYHA functional class III patients is safe and results in a low rate of HF hospitalizations and mortality over 12 months. These results support the use of seated mPAP monitoring and extend the evidence that pulmonary artery pressure-guided management improves HF outcomes. (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients [PROACTIVE-HF Trial]; NCT04089059).
Affiliations
Advocate Christ Medical Center