AVF-MONITOR POC Proof-of-concept Study

NCT07318025 | Not Yet Recruiting

• 1 other identifier: AVF-MONITOR POC
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proof-of-concept single-centre prospective longitudinal interventional study performed in AVF patients under HD treatment at the Nephrology and Dialysis Department of the ASST-Papa Giovanni XXIII (Bergamo, Italy), involving the recording of AVF sounds by the AVF-MONITOR wearable prototype device. Participants will undergo a screening and enrollment visit, then follow-up visits for AVF sounds registration will be conducted once a week for all participants, prior to dialysis session, over a period of 8 weeks.

Conditions

Hemodyalysis

Keywords

arteriovenous fistula; hemodialysis; vascular access; monitoring; sound recording; proof-of-concept study; prototype device; vascular stenosis

Outcome Measures

Primary Outcomes (1)

• High-low peak ratio

  Correlation between the high-low peak ratio (HLPR) calculated from acoustic recordings obtained using the AVF-MONITOR device (in Hz) and the gold standard electronic stethoscope (in Hz).

  Once weekly for 8 weeks after the initial screening and enrollment visit

Study Arms (1)

Patients

EXPERIMENTAL

Patients undergoing HD with a functioning native AVF

Device: AVF MONITOR

Interventions

AVF MONITOR DEVICE

Wearable non-invasive device consisting in an electronic platform that can acquire acoustic data by means of an analog microphone.

Patients

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent prior to any study specific procedures.
• Female and/or male aged ≥ 18.
• Patients undergoing HD with a mature and functioning native AVF.

You may not qualify if:

• Patients with a history of complications related to the AVF in use.
• Patients who use a graft or catheter to perform HD.
• Patients with reduced life expectancy (less than 1 year).

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

ASST HPG23 - Unità di Nefrologia

Bergamo, BG, Italy

Location

Related Publications (6)

• Poloni S, Soliveri L, Caroli A, Remuzzi A, Bozzetto M. The Potential of Sound Analysis to Reveal Hemodynamic Conditions of Arteriovenous Fistulae for Hemodialysis. Ann Biomed Eng. 2025 Jan;53(1):230-240. doi: 10.1007/s10439-024-03638-2. Epub 2024 Nov 1.

  PMID: 39485642 BACKGROUND

• Poloni S, Condemi CG, Peracchi T, Caroli A, Remuzzi A, Bozzetto M. Leveraging Acoustic Analysis to Detect Arteriovenous Fistula Complications. Kidney360. 2025 Oct 1;6(10):1771-1779. doi: 10.34067/KID.0000000840. Epub 2025 Jun 10.

  PMID: 40493416 BACKGROUND

• Roy-Chaudhury P, Arend L, Zhang J, Krishnamoorthy M, Wang Y, Banerjee R, Samaha A, Munda R. Neointimal hyperplasia in early arteriovenous fistula failure. Am J Kidney Dis. 2007 Nov;50(5):782-90. doi: 10.1053/j.ajkd.2007.07.019.

  PMID: 17954291 BACKGROUND

• Bozzetto M, Poloni S, Caroli A, Curto D, D'Haeninck A, Vanommeslaeghe F, Gjorgjievski N, Remuzzi A. The use of AVF.SIM system for the surgical planning of arteriovenous fistulae in routine clinical practice. J Vasc Access. 2023 Sep;24(5):1061-1068. doi: 10.1177/11297298211062695. Epub 2022 Jan 6.

  PMID: 34986688 BACKGROUND

• Caroli A, Manini S, Antiga L, Passera K, Ene-Iordache B, Rota S, Remuzzi G, Bode A, Leermakers J, van de Vosse FN, Vanholder R, Malovrh M, Tordoir J, Remuzzi A; ARCH project Consortium. Validation of a patient-specific hemodynamic computational model for surgical planning of vascular access in hemodialysis patients. Kidney Int. 2013 Dec;84(6):1237-45. doi: 10.1038/ki.2013.188. Epub 2013 May 29.

  PMID: 23715122 BACKGROUND

• Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.

  PMID: 24183112 BACKGROUND

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Remuzzi, M.D.

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY DIRECTOR

Central Study Contacts

Michela Bozzetto

CONTACT

+3903545351; michela.bozzetto@marionegri.it

Study Design

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

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)