Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device (DRIVE-ID)

The aim of this single center observational study is to determine the feasibility of using non-invasive imaging methods, including smartphone photography and infrared thermography, for detecting of DLIs in LVAD patients in terms of severity, extent and natural healing process.

Study Overview

• Status: Enrolling by invitation
• Conditions: LVAD (Left Ventricular Assist Device) Driveline Infection

Detailed Description

Observational data of the driveline exit of LVAD patients will be collected during a follow-up period of 26 weeks. Two non-invasive imaging methods will be used.

Smartphone photos will be taken weekly by the patient during routine wound care in the home environment.

In case the patient is admitted for driveline infection, infrared thermographic (IRT) photography will be used to make thermographic photos of the driveline exit and the abdominal area of the subcutaneous driveline.

Furthermore, existing smartphone images and diagnostic data regarding prior DLI status will be obtained from the electronic patient records.

Imaging data will additionally be retrospectively analyzed using artificial intelligence (AI) and machine learning for the development of a predictive AI model.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands
    • Erasmus MC

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with an LVAD

Description

Inclusion Criteria: Patients age 16 years or older, implanted with an LVAD, followed at Erasmus MC, with access to a smartphone with a built-in camera, who have signed an informed consent for data collection.

Exclusion Criteria: Known cognitive problems, like dementia etc., non-cardiac disease or cardiac diseases resulting in a life expectancy less than 1 years, inability to read or sign the informed consent form.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients implanted with an LVAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent and severity of driveline infections in LVAD patients using non-invasive imaging	Assess the extent, severity, and healing process of LVAD driveline infections in patients on LVAD support	26 weeks
Driveline exit healing process and risk of infection of the LVAD driveline	Assess the healing process of the driveline exit using non-invasive imaging (smartphone and thermographic)	26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sceptic complications	Occurance of systemic infection, positive blood cultures, and VAD-related infections.	26 weeks
Machine learning model for predicting DLIs.	Assess whether a machine learning model can be developed and validated based on smartphone photography and IRT to predict the occurrence of DLIs.	26 weeks

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Eindhoven University of Technology
• Investigators: Principal Investigator: K. Caliskan, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Detection; Infection; Imaging; Monitoring; Non-invasive; LVAD; Driveline infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: MEC-2023-0597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Imaging data will be de-identified and then shared with Eindhoven University of Technology for further analyses and modeling.
• IPD Sharing Time Frame: Data transfer is anticipated 1 October 2024 and 1 July 2025
• IPD Sharing Access Criteria: Coordinating researcher V. Drost will be able to access the IPD and supporting information via the investigation site.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No