NCT06867887

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 16 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• LVAD (Left Ventricular Assist Device) Driveline Infection

Timeline

• Start date: 2024-02-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: Netherlands