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KV-PREDICT Diagnostic Device in Patients With Heart Failure (PREDICT_HF)

3 september 2026 uppdaterad av: KardioVis S.r.l.

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

120

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Italien
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italien, 41124
        • S.C. Cardiologia, Azienda Ospedaliero-Universitaria Policlinico di Modena
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: KV-PREDICT signal acquisition
Single group of adult heart failure patients undergoing one non-invasive KV-PREDICT signal acquisition during a scheduled outpatient visit.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals
Tidsram: 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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Quality and suitability of KV-PREDICT recordings for extraction of mechanical gyroscopic signals
Tidsram: 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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles
Tidsram: 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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Variability of acquired gyroscopic signals' amplitude across NYHA classes and left-ventricular function profiles
Tidsram: 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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Variability of acquired acceleration signals' timing across NYHA classes and left-ventricular function profiles
Tidsram: 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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Variability of acquired gyroscopic signals' timing across NYHA classes and left-ventricular function profiles
Tidsram: 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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)
Adverse events or complaints related to the procedure for data acquisition
Tidsram: 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
During the single signal-acquisition session at the scheduled study visit (about 10 seconds of recording)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

KardioVis S.r.l.

Utredare

  • Huvudutredare: Giuseppe Boriani, MD, PhD, Azienda Ospedaliero-Universitaria di Modena

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 april 2027

Avslutad studie (Beräknad)

1 april 2027

Studieregistreringsdatum

Först inskickad

25 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

3 september 2026

Första postat (Faktisk)

4 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PREDICT-HF
  • 26-06-058156 (Annan identifierare: EUDAMED (European Database on Medical Devices))

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant-level physiological signal data are proprietary and commercially sensitive to ongoing device development; the pilot, exploratory design did not provision for external data sharing. Anonymized results will be disseminated through scientific publications.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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