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OpenTrials
Enrolling by Invitation

NCT Number: NCT06867887

Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device

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.

Enrolling by Invitation

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Key information

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC

Rotterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Extent and severity of driveline infections in LVAD patients using non-invasive imaging

    Time frame: 26 weeks

    Assess the extent, severity, and healing process of LVAD driveline infections in patients on LVAD support

  2. Driveline exit healing process and risk of infection of the LVAD driveline

    Time frame: 26

    Assess the healing process of the driveline exit using non-invasive imaging (smartphone and thermographic)

Secondary outcomes

  1. Sceptic complications

    Time frame: 26 weeks

    Occurance of systemic infection, positive blood cultures, and VAD-related infections.

  2. Machine learning model for predicting DLIs.

    Time frame: 26 weeks

    Assess whether a machine learning model can be developed and validated based on smartphone photography and IRT to predict the occurrence of DLIs.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Eindhoven University of Technology

Registry information

Acronym: DRIVE-ID

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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