Helsingborg, Sweden – November 04, 2024
“CAPTURE-HF represents the largest reported international effort to compare non-invasive hemodynamic measures with those obtained simultaneously using gold standard right heart catheterization technique and blinded core lab oversight as part of a prospective registry. On behalf of all the investigators involved, we are proud to see Acorai complete enrollment and achieve this momentous milestone for the benefit of our field continuing to innovate how we assess congestion in patients suffering from heart failure at the point of care.” – Dr. Andrew J. Sauer, Associate Director, St. Lukes Kansas City, USA
Acorai, a leader in non-invasive cardiovascular technology, is proud to announce the successful completion of patient enrollment for its 1600-patient CAPTURE-HF study. This milestone marks a crucial step in the development and validation of Acorai’s non-invasive cardiac and pulmonary sensing device, which has been developed to enable reliable and actionable insights for improved heart failure patient management.
The CAPTURE-HF study is a two-phase data acquisition study designed to evaluate the accuracy, safety, and usability of Acorai’s device in assessing cardiac and pulmonary pressures, with patients compared against a right heart catheterization gold standard.
Acorai enrolled a total of 1,600 patients across 20 clinical sites in six countries, with 1,300 participants in Phase 1 for further product development and over 300 participants in Phase 2 for validation, with over half of the patients enrolled from U.S. sites. The study’s comprehensive design will support regulatory submissions across Europe and the U.S. and inform future developments of Acorai’s technology.
“Completing enrollment in the CAPTURE-HF study is a pivotal achievement in our mission to transform heart failure management. I am proud of the incredible effort that has gone into this study by our clinical team and the excitement that our device has received from patients and healthcare professionals involved in the study.” said Filip Peters, CEO of Acorai. “Our goal is to address a large unmet need in cardiology by equipping clinicians with crucial non-invasive data for heart failure patient management that is both reliable and actionable.”
The study results are expected in the first half of 2025, providing the foundation for Acorai’s regulatory submissions across the U.S. and Europe, and future innovations in non-invasive cardiac care. By providing clinicians with non-invasive, actionable information into heart failure patients’ hemodynamic status, Acorai’s device has the potential to transform personalized heart failure patient care.
For more information on Acorai and the CAPTURE-HF study, visit ClinicalTrials.gov.
About Acorai
Acorai is dedicated to advancing non-invasive cardiovascular care, focused on improving patient outcomes and empowering clinicians with next-generation technology for enhanced patient management. Acorai’s patented SAVE Sensor System, a first-of-its-kind, multi-modal sensing platform, received FDA Breakthrough Device Designation in 2023, enabling Acorai’s participation in the FDA’s Total Product Life Cycle Advisory Program (TAP). Supported by leading institutional medtech investors, healthcare systems, and strategic partners, Acorai is committed to shaping the future of cardiac care through non-invasive innovation.
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