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

3 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: KV-PREDICT signal acquisition
Single group of adult heart failure patients undergoing one non-invasive KV-PREDICT signal acquisition during a scheduled outpatient visit.
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

KardioVis S.r.l.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 avril 2027

Dates d'inscription aux études

Première soumission

25 août 2026

Première soumission répondant aux critères de contrôle qualité

3 septembre 2026

Première publication (Réel)

4 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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