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KV-PREDICT Diagnostic Device in Patients With Heart Failure
Sponsor: KardioVis S.r.l.
Summary
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.
Official title: Single-Centre, Interventional, Non-Invasive Clinical Study to Evaluate the Performance of the KV-PREDICT Diagnostic Medical Device in Patients With Heart Failure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-09
Completion Date
2027-04
Last Updated
2026-09-04
Healthy Volunteers
No
Conditions
Interventions
KV-PREDICT
KV-PREDICT is applied externally to the chest, over clothing (no skin contact required), during a scheduled outpatient visit. It performs a single acquisition of about 10 seconds, simultaneously recording a single-lead ECG and cardiac mechanical vibration signals. The embedded software only acquires, filters, synchronizes and transmits the signals; it produces no automated clinical output or interpretation. During the same session, an external, standalone reference pulse oximeter (photoplethysmograph), which is not connected to and not part of the investigational device, is recorded separately and used only for offline comparison during signal analysis. All signals are analyzed offline for research purposes only.
Locations (1)
S.C. Cardiologia, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Emilia-Romagna, Italy