KV-PREDICT Diagnostic Device in Patients With Heart Failure

NCT07805213 | Not Yet Recruiting

• 2 other identifiers: PREDICT-HF26-06-058156
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

seismocardiography; cardiac mechanical signals; heart sounds; non-invasive cardiac monitoring; device feasibility; cardiac time intervals; gyrocardiography; cardiac mechanical vibrations

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 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 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 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)

• 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)

Study Arms (1)

KV-PREDICT signal acquisition

EXPERIMENTAL

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

Device: KV-PREDICT

Interventions

KV-PREDICT DEVICE

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.

KV-PREDICT signal acquisition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KardioVis S.r.l.: lead

Study Sites (1)

S.C. Cardiologia, Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, Emilia-Romagna, 41124, Italy

Location

Related Publications (5)

• 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.

  PMID: 28754888 BACKGROUND

• 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.

  PMID: 37522900 BACKGROUND

• 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.

  PMID: 18514937 BACKGROUND

• 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.

  PMID: 31634574 BACKGROUND

• 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.

  PMID: 37076404 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Giuseppe Boriani, MD, PhD

  Azienda Ospedaliero-Universitaria di Modena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Pieraccini, MSc / Eng.

CONTACT

+39 351 5548005; gabriele.pieraccini@kardiovis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)