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

NCT ID: NCT06867887

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-12

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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LVAD (Left Ventricular Assist Device) Driveline Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients implanted with an LVAD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eindhoven University of Technology

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kadir Caliskan MD, PhD, FESC

Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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K. Caliskan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC-2023-0597

Identifier Type: -

Identifier Source: org_study_id

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