NCT06867887

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Feb 2024Dec 2026

Study Start

First participant enrolled

February 12, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 10, 2025

Status Verified

September 1, 2024

Enrollment Period

2.9 years

First QC Date

September 5, 2024

Last Update Submit

March 5, 2025

Conditions

LVAD (Left Ventricular Assist Device) Driveline Infection

Keywords

InfectionLVADDetectionMonitoringDriveline infectionImagingNon-invasive

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Sceptic complications

    26 weeks

  • Machine learning model for predicting DLIs.

    26 weeks

Study Arms (1)

Patients implanted with an LVAD

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients implanted with an LVAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Infections

Study Officials

  • K. Caliskan, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
26 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

September 5, 2024

First Posted

March 10, 2025

Study Start

February 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 10, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Imaging data will be de-identified and then shared with Eindhoven University of Technology for further analyses and modeling.

Shared Documents
STUDY PROTOCOL
Time Frame
Data transfer is anticipated 1 October 2024 and 1 July 2025
Access Criteria
Coordinating researcher V. Drost will be able to access the IPD and supporting information via the investigation site.

Locations

NL(1)