Heart Failure
Conditions
Keywords
seismocardiography, cardiac mechanical signals, heart sounds, non-invasive cardiac monitoring, device feasibility, cardiac time intervals, gyrocardiography, cardiac mechanical vibrations
Brief 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.
Detailed description
Background and rationale Heart failure is a chronic condition in which periodic clinical assessment is important for follow-up. Non-invasive tools that can be used quickly during routine outpatient visits are of interest as a complement to established assessment methods. KV-PREDICT is an investigational diagnostic medical device (Class IIa, not CE-marked) developed to acquire cardiac electrical and mechanical signals non-invasively. Before any evaluation of clinical or predictive performance, it is first necessary to confirm that the device, in its current prototype configuration, can reliably acquire signals of adequate quality across patients with different degrees of heart failure severity. Objective and nature of the study This is a single-center, non-invasive, interventional pilot study of exploratory nature. Its purpose is limited to assessing the feasibility, quality and reproducibility of the signals acquired by KV-PREDICT. The study does not evaluate the diagnostic or predictive performance of the device, is not designed to support any clinical decision, and does not modify the clinical management of participants in any way. Study conduct Eligible patients are enrolled during a scheduled outpatient follow-up visit, after providing written informed consent. Each participant undergoes a single, brief signal-acquisition session performed with the device applied externally to the chest, over clothing, without any invasive procedure and without interfering with the standard clinical visit. No dedicated follow-up visits are required for the purposes of this study. Data handling and analysis The acquired signals are used exclusively for research purposes and are analyzed offline, after the acquisition session, outside the clinical setting. No automated interpretation or clinical output is generated by the device during the visit. Analyses are descriptive and exploratory, consistent with the pilot nature of the study. Expected value and risks No direct clinical benefit to individual participants is expected. Because the procedure is non-invasive and brief, the anticipated risks and burden for participants are minimal. The results are intended to inform the subsequent development of the device.
Interventions
DEVICEKV-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.
Sponsors
KardioVis S.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals | During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording) | Number and corresponding percentage of technically valid and processable acceleration signal acquisitions measured in mG, across patients with different heart-failure severity |
| Quality and suitability of KV-PREDICT recordings for extraction of mechanical gyroscopic signals | During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording) | Number and corresponding percentage of technically valid and processable gyroscopic signal acquisitions measured in mDeg/s, across patients with different heart-failure severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles | During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording) | Variability of amplitude of acceleration signals measured in mG across NYHA classes and left-ventricular function profiles |
| Variability of acquired gyroscopic signals' amplitude across NYHA classes and left-ventricular function profiles | During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording) | Variability of amplitude of gyroscopic signals' amplitude measured in mDeg/s across NYHA classes and left-ventricular function profiles |
| Variability of acquired acceleration signals' timing across NYHA classes and left-ventricular function profiles | During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording) | Variability of timing of acceleration signals measured in ms across NYHA classes and left-ventricular function profiles |
| Variability of acquired gyroscopic signals' timing across NYHA classes and left-ventricular function profiles | During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording) | Variability of timing of gyroscopic signals measured in ms across NYHA classes and left-ventricular function profiles |
| Adverse events or complaints related to the procedure for data acquisition | During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording) | Number of adverse events or complaints collected during the recording sessions |
Countries
Italy
Contacts
CONTACTGabriele Pieraccini, MSc / Eng.
PRINCIPAL_INVESTIGATORGiuseppe Boriani, MD, PhD
Azienda Ospedaliero-Universitaria di Modena
Outcome results
None listed