Publications - Acorai

Clinical & Publications

Current Clinical Program

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SAVE-CATH [400 patients – 5 hospitals – US, EU]

Clinical validation against right heart catheterization to support FDA 510(k) clearance.

SAVE-CATH is Acorai’s planned clinical validation study to support FDA 510(k) regulatory submission. The study will evaluate the final-generation Acorai device against right heart catheterization, the clinical gold standard for intracardiac hemodynamic assessment. Designed as an observational, single-arm controlled study, SAVE-CATH is expected to enroll approximately 400 patients across U.S. and European sites, with each patient undergoing a short, non-invasive Acorai sensor recording during their standard-of-care catheterization procedure. The primary objective is to validate Acorai’s machine learning models for estimating intracardiac hemodynamic parameters non-invasively.

HOSP-HF [1000 patients – 11 hospitals – US, EU, SEA]

Daily inpatient congestion monitoring to support discharge readiness and improve heart failure outcomes.

HOSP-HF is Acorai’s hospitalized heart failure study program, designed to generate health economic and outcomes evidence for the use of non-invasive congestion monitoring in inpatient care. The observational phase will study approximately 1,000 hospitalized heart failure patients across the U.S., Singapore and Europe, using daily Acorai measurements during hospitalization to assess whether improved decongestion at discharge is associated with better 90-day outcomes, including readmissions and adverse events. A subsequent interventional phase is planned to evaluate whether implementing Acorai in clinical workflows can improve patient outcomes, reduce readmissions, lower cost of care and support quality-of-life improvements.

AHEAD-HF [600 patients – 1 hospital – SEA]

Rapid emergency department assessment to help accelerate decisions in suspected acute heart failure.

AHEAD-HF is Acorai’s planned emergency department study in patients with suspected acute heart failure. The study is designed to evaluate whether a rapid, 5-minute Acorai measurement can support earlier clinical decision-making by reducing door-to-decision time while maintaining non-inferior clinical performance compared with standard-of-care assessments such as natriuretic peptide testing or chest imaging. Planned as an observational, single-arm study in approximately 600 adult emergency department patients in Singapore, AHEAD-HF will assess whether Acorai measurements can be available before key emergency care milestones, including treatment decisions, imaging results and disposition decisions.