Product Validation

KardioVis will follow a phased validation strategy designed to minimize risk and build robust clinical evidence.

Phase 1 — Funded with current resources

A first Clinical Validation Study will be conducted at the Cardiology Department of the University of Modena, under the direction of Prof. Giuseppe Boriani as Principal Investigator. The study aims to enroll 120 patients over a 12-month period. Prof. Boriani is a globally recognized authority in implantable devices, heart failure, and health economics.

Preliminary findings from this study are intended to be submitted to leading international peer-reviewed cardiology journals (e.g., Europace).

Phase 2 — Global clinical validation

A subsequent multi-centre international study is planned to further evaluate the device’s performance and its potential role in supporting early heart failure risk assessment.

This phase will contribute to the clinical evidence required for MDR and FDA regulatory submissions, supporting the pathway toward global market authorization.

Phase 1 (ongoing)

Clinical study with Modena University Hospital and the Italian Health Ministry.

Key Data:

  • 120 Patients.

  • Modena University Hospital.

  • Lead physician: Prof. Giuseppe Boriani (Scientific Advisor).

  • In collaboration with the Italian Health Ministry (Ministero della Salute).

Timeplan:

  • January 2026: Clinical study application

  • March 2026: Clinical study starts.

  • March 2027: Clinical study completion.

A large multi-story building surrounded by trees and a park with bushes in the foreground under a clear blue sky. Modena Hospital
Italian Ministry of Health logo with text 'Ministero della Salute' in elegant script
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Scientific References

References to Heart Failure Problem

  • Nat Rev Cardiol. 2016 June ; 13(6): 368–378. doi:10.1038/nrcardio.2016.25.

  • Global epidemiology and future trends of heart failure. AME Med J 2020;5:15.

  • European Journal of Heart Failure (2016) 18, 242–252).

  • Clin Res Cardiol (2017) 106:913–922. D  OI 10.1007/s00392-017-1137-7

  • Worldwide statistics on Population Pyramid: https://www.populationpyramid.net

  • The Global Health and Economic Burden of Hospitalizations for Heart Failure. J Am Coll Cardiol 2014;63:1123–33.

  • HF STATS2025. Journal of Cardiac Failure 00 (2025) 1 60

  • J Cardiac Fail 2020;26:151 159

  • ESC Heart Failure 2021; 8: 1571–1581

  • J Card Fail. 2008 June ; 14(5): 431–436

  • Heart Rhythm 2023;20:572–579

  • J Am Coll Cardiol Basic Trans Science 2022; 7:313-315

  • J. Clin. Med. 2022, 11, 3862

  • European Heart Journal - Digital Health (2025) 6, 486–495

  • JAmCollCardiolHF2024;12:1030–1040

  • European Heart Journal - Digital Health (2022) 3, 473–480

  • Circ HF 2020; 13:e0065e. DOI:1161/CIRCHEARTFAILURE.119.006513

  • JACC: BASIC TO TRANSLATIONAL SCIENCE VOL. 8, NO. 4, 2023.  APRIL 2023:377–379

References Supporting the KardioVis Approach

  • N Engl J Med 2001; 345:574-81

  • J Cardiac Fail 2020;26:151 159

  • ESC Heart Failure 2021; 8: 1571–1581

  • European Journal of Internal Medicine 115 (2023) 1–9

  • Ann Noninvasive Electrocardiol. 2022;27:e12932

  • J Card Fail. 2008 June ; 14(5): 431–436

  • Clinical Research in Cardiology (2025) 114:430–442

  • The International Journal of Cardiac Imaging 2024. 40:2145-55

  • www.nature.com/scientificreports/

  • (NATURE) SCIENTIFIC REPORTS | 7: 6823 | DOI:10.1038/s41598-017-07248-y

  • Heart Rhythm 2023;20:572–579

References to Heart Failure Market

  • J Am Heart Assoc. 2023;12:e027852. DOI: 10.1161/JAHA.122.027852

  • Circulation. 2025;151:e41–e660. DOI: 10.1161/CIR.0000000000001303 

  • Clin Res Cardiol (2017) 106:913–922

  • J Manag Care Spec Pharm.  2022;28(2):157-67

  • HFSTAT_Journalof Cardiac Failure 00 (2025) 1 60