PROACTIVE-HF: Cordella PA Sensor Improves HF Status Regardless of EF

The Cordella Pulmonary Artery (PA) sensor system is associated with improved status in patients with heart failure (HF) regardless of ejection fraction (EF), according to 2-year data from the PROACTIVE-HF trial.1

The Cordella PA Sensor is a microelectromechanical system sensor implanted in the right pulmonary artery, which enables pulmonary artery pressure (PAP) reading from the anterior chest wall via a handheld reader when patients are in either the seated or supine posture. The system is designed to provide clinicians with a patient’s supine and/or seated PAP, blood pressure (BP), heart rate (HR), body weight, and oxygen saturation (SpO2).1

“The odds would tell you that the majority of patients would probably see a hospitalization within 2 years,” Jason Guichard, MD, PhD, advanced heart failure and transplant cardiologist at Prisma Health and lead investigator on the study, told HCPLive in an exclusive interview. “The fact that the Cordella PA sensor system was able to keep these patients out and alive is quite remarkable.”

PROACTIVE-HF was a prospective, open-label, single-arm, multicenter clinical trial aiming to evaluate the safety and efficacy of the Cordella PA sensor system in patients with New York Heart Association (NYHA) Class III HF compared to a performance goal. Patients with a diagnosis of and treatment for HF for ≥3 months who were on stable, optimally titrated medical therapy for ≥30 days and had an HF-related hospitalization within 12 months at the time of screening, among other criteria, were eligible for inclusion; those with ACC/AHA Stage D refractory HF, a history of recurrent pulmonary embolism, or unrepaired severe valvular disease, among other criteria, were excluded.2

All enrolled patients were instructed to take daily vital signs, including HR, BP, weight, and SpO2. Following implantation of the Cordella PA sensor, patients were treated to a target trend seated mean PAP of 5-20 mmHg, which was achieved through titration of vasodilators, diuretics, and guideline-directed medical therapy (GDMT) via a trial-specific guideline. The team defined trend-seated mean PAP as a 7-day moving average of daily mean PAP readings.1

The primary endpoint for the trial was 24-month incidence of HF events or all-cause mortality. HF events included first or recurrent HF hospitalization and outpatient intravenous diuretic visits. Secondary outcomes included change from baseline in PAP, vital signs, NT-proBNP, KCCQ, HF medication changes, and patient compliance.1

A total of 456 patients were implanted with a sensor – of these, 45.6% (n = 208) had HF with reduced EF (HFrEF), 44.1% (n = 201) had HF with preserved EF (HFpEF), and 9.9% had HF with mildly reduced EF (HFmrEF). Another 2 patients did not have an EF assessment at baseline. During the first 24 months, the incidence of HF events and cardiovascular mortality was 0.89 (95% CI, 0.81-0.99) events per patient. Additionally, patients with HFrEF had greater HF events and cardiovascular mortality rates than those with HFpEF (1.0 vs 0.8 events per patient; P = .048).1

Guichard and colleagues also noted KCCQ overall scores 5.1 points higher than at baseline, substantially improving for both patients with HFpEF and HFrEF. NT-proBNP was largely unchanged across all cohorts, although NYHA class improved across all arms. Body weights were reduced at 24 months (103.7 +/- 25.8 vs 100.9 +/- 24.5 kg; P <.0001) in HFpEF, but not in HFrEF (101.6 +/- 25.8 vs 100.8 +/- 24; P = 0.72). Patients saw no significant changes in home readings of systolic or diastolic BP or in HR measurements in any group.1

Ultimately, Guichard and colleagues concluded that management with the Cordella PA sensor system substantially improves health status at 2 years, independent of EF. These results also represent an extension of the positive 6- and 12-month outcomes of PROACTIVE-HF, supporting wider adoption of seated mean PAP-guided management to improve symptoms and quality of life for multiple years.1

“We have come a long way in reducing heart failure hospitalizations, and we’ve learned a lot on how to identify these patients, how to manage them, and how to do so efficiently and effectively,” Guichard said. “I would love to see a day where we get 95%, maybe even 99% avoiding hospitalizations and avoiding heart failure decomposition in general, and hopefully that’ll get patients living better and living longer.”

Editors’ Note: Guichard reports no relevant disclosures.

References

1. Guichard J, Bonno E, Nassif M, et al. Two-year results of proactive-HF trial stratified by left ventricular ejection fraction. Journal of Cardiac Failure. Published online March 13, 2026. doi:10.1016/j.cardfail.2026.01.023

2. Endotronix, Inc. PROACTIVE-HF IDE Trial Heart Failure NYHA Class III (PROACTIVE-HF). ClinicalTrials.gov Identifier: NCT04089059. Updated March 3, 2025. Accessed May 26, 2026. https://clinicaltrials.gov/study/NCT04089059