SEISMIC-HF I Data Published for Cardiosense’s CardioTag and Machine Learning Algorithm

June 25, 2025—Cardiosense announced that results from the SEISMIC-HF I study demonstrated the ability of the company’s machine learning (ML) algorithm to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in patients with heart failure with reduced ejection fraction (HFrEF).

The prospective, multicenter SEISMIC-HF I study enabled the development and evaluation of Cardiosense’s ML algorithm in 310 patients with HFrEF undergoing right heart catheterization (RHC), noted the press release. The company further stated that the study population enrolled a diverse set of participants with demographics and clinical characteristics reflective of the broader population with HFrEF to ensure ML models generalize across all patients.

The study findings were published by Liviu Klein MD, et al in JACC: Heart Failure. Initial results from SEISMIC-HF I were presented last November at AHA 2024, the American Heart Association’s scientific sessions, stated the company.

According to Cardiosense, patients enrolled in the study wore the company’s CardioTag device on the sternum during their RHC procedure to provide gold-standard assessment of the PCWP. CardioTag is a multimodal sensor that captures seismocardiogram, electrocardiogram, and photoplethysmogram signals.

Cardiosense reported that the 15-site study showed that the device estimated absolute PCWP values with accuracy on par with implantable hemodynamic sensors, suggesting that the noninvasive, artificial intelligence–enabled technology has the potential to increase access to hemodynamic-guided care. Additionally, the study demonstrated consistent performance across sex, race, ethnicity, and body mass index.

“Heart failure management remains one of our most significant clinical challenges and most promising opportunities to directly impact patient outcomes,” commented Dr. Klein in the Cardiosense press release. “We know that hemodynamic-guided care reduces hospital readmissions and mortality, yet routine cardiac pressure measurements remain inaccessible due to cost and risk.

“SEISMIC-HF I is a critical advancement toward the quest for noninvasive technology delivering on the promise of fast, safe, and accessible pressure-guided heart failure management.”

The CardioTag device and PCWP analysis software are limited to investigational use and are not available for commercial distribution, advised Cardiosense.

On May 28, the company announced the launch of the SEISMIC-HF II study to validate the company’s ML algorithm for assessing intracardiac filling pressure, an early indicator of acute heart failure decompensation. The prospective, multicenter, blinded study will collect data from patients undergoing RHC across multiple geographically diverse sites in the United States. Cardiosense’s noninvasive PCWP estimate will be compared to the RHC measurements to validate the performance of the algorithm.