Tests a heart monitoring device in people with heart failure
Tests whether a chest device records heart signals well in adults with heart failure.
Plain-language title generated from the registry record
Registry title: KV-PREDICT Diagnostic Device in Patients With Heart Failure
Key facts
- Where
- Modena, ItalySee the site
Where in Italy
- S.C. Cardiologia, Azienda Ospedaliero-Universitaria Policlinico di ModenaModena, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- KardioVis S.r.l.
- Trial code
- NCT07805213
- Record updated
- 4 September 2026
- Original description
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.Read full original descriptionShow less
Single-Centre, Interventional, Non-Invasive Clinical Study to Evaluate the Performance of the KV-PREDICT Diagnostic Medical 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: 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: Concurrent participation in other studies that could interfere with the aims of this investigation; Conditions that, in the investigator's judgment, could interfere with correct performance of the acquisition procedure; Acute clinical instability at the time of the visit; Inability to provide valid informed consent.