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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: KV-PREDICT

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriele Pieraccini, MSc / Eng.; Phone Number: +39 351 5548005; Email: gabriele.pieraccini@kardiovis.com

Study Locations

• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41124
      • S.C. Cardiologia, Azienda Ospedaliero-Universitaria Policlinico di Modena
      • Contact: Study Principal Investigator; Phone Number: +39 059 4225463; Email: giuseppe.boriani@unimore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: KV-PREDICT signal acquisition; Single group of adult heart failure patients undergoing one non-invasive KV-PREDICT signal acquisition during a scheduled outpatient visit.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality and suitability of KV-PREDICT recordings for extraction of mechanical acceleration signals	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variability of acquired acceleration signals' amplitude across NYHA classes and left-ventricular function profiles	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	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	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	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	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)

Collaborators and Investigators

• Sponsor: KardioVis S.r.l.
• Investigators: Principal Investigator: Giuseppe Boriani, MD, PhD, Azienda Ospedaliero-Universitaria di Modena

Publications and helpful links

General Publications

• Shah SJ, Nakamura K, Marcus GM, Gerber IL, McKeown BH, Jordan MV, Huddleston M, Foster E, Michaels AD. Association of the fourth heart sound with increased left ventricular end-diastolic stiffness. J Card Fail. 2008 Jun;14(5):431-6. doi: 10.1016/j.cardfail.2008.01.010. Epub 2008 May 27.
• Jafari Tadi M, Lehtonen E, Saraste A, Tuominen J, Koskinen J, Teras M, Airaksinen J, Pankaala M, Koivisto T. Gyrocardiography: A New Non-invasive Monitoring Method for the Assessment of Cardiac Mechanics and the Estimation of Hemodynamic Variables. Sci Rep. 2017 Jul 28;7(1):6823. doi: 10.1038/s41598-017-07248-y.
• Alhakak AS, Olsen FJ, Skaarup KG, Lassen MCH, Johansen ND, Jorgensen PG, Abildgaard U, Jensen GB, Schnohr P, Sogaard P, Mogelvang R, Biering-Sorensen T. Age- and sex-based normal reference ranges of the cardiac time intervals: the Copenhagen City Heart Study. Clin Res Cardiol. 2025 Apr;114(4):430-442. doi: 10.1007/s00392-023-02269-2. Epub 2023 Jul 31.
• Cao M, Gardner RS, Hariharan R, Nair DG, Schulze C, An Q, Thakur PH, Kwan B, Zhang Y, Boehmer JP. Ambulatory Monitoring of Heart Sounds via an Implanted Device Is Superior to Auscultation for Prediction of Heart Failure Events. J Card Fail. 2020 Feb;26(2):151-159. doi: 10.1016/j.cardfail.2019.10.006. Epub 2019 Oct 18.
• Boriani G, Imberti JF, Bonini N, Carriere C, Mei DA, Zecchin M, Piccinin F, Vitolo M, Sinagra G. Remote multiparametric monitoring and management of heart failure patients through cardiac implantable electronic devices. Eur J Intern Med. 2023 Sep;115:1-9. doi: 10.1016/j.ejim.2023.04.011. Epub 2023 Apr 17.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 25, 2026
• First Submitted That Met QC Criteria: September 3, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: non-invasive cardiac monitoring; seismocardiography; heart sounds; cardiac mechanical signals; device feasibility; cardiac time intervals; gyrocardiography; cardiac mechanical vibrations
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: PREDICT-HF; 26-06-058156 (Other Identifier: EUDAMED (European Database on Medical Devices))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No