KV-PREDICT Diagnostic Device in Patients With Heart Failure

This is a pilot, single-center, non-invasive interventional study evaluating the performance of KV-PREDICT, an investigational diagnostic medical device (Class IIa, not CE-marked), in adult patients with heart failure. During a single scheduled outpatient visit, the device is placed externally on the chest, over clothing, and records a single-lead ECG together with cardiac mechanical vibration signals for about 10 seconds. The study assesses whether the device can acquire signals of adequate quality and reproducibility to allow extraction of mechanical and electromechanical cardiac parameters (such as systolic and diastolic time intervals and the amplitudes of mechanical vibrations corresponding to the heart sounds S1-S4). The study does not aim to support clinical decisions, does not change patient management, and does not evaluate the diagnostic or predictive performance of the device. About 120 patients across NYHA functional classes I-III and different left-ventricular function profiles will be enrolled. No direct clinical benefit to participants is expected; anticipated risks are minimal given the non-invasive, brief procedure.

Inclusion Criteria: * Age 18 years or older * Clinical diagnosis of heart failure * NYHA functional class I, II, or III * Able to understand the study information and provide written informed consent * Attending a scheduled outpatient follow-up visit at the site Exclusion Criteria: * Acute clinical instability at the time of the visit * Conditions that, in the investigator's judgment, could interfere with correct performance of the acquisition procedure * Inability to provide valid informed consent * Concurrent participation in other studies that could interfere with the aims of this investigation