LVAD (Left Ventricular Assist Device) Driveline InfectionDRIVE-IDNCT06867887
Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
An observational study of LVAD (Left Ventricular Assist Device) Driveline Infection, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- LVAD (Left Ventricular Assist Device) Driveline Infection
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Feb 2024to 31 Dec 2026
- How long will I take part?
- 26 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with an LVAD
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Keywords
- Infection, LVAD, Detection, Monitoring, Driveline infection, Imaging, Non-invasive
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with an LVAD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 26
Secondary outcomes (2)
Sceptic complications
Occurance of systemic infection, positive blood cultures, and VAD-related infections.
Measured: 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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start12 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LVAD (Left Ventricular Assist Device) Driveline InfectionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 26 Weeks
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Principal investigator, Kadir Caliskan MD, PhD, FESC, Erasmus Medical Center
- Investigators
- K. Caliskan, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867887
- Sponsor's protocol ID
- MEC-2023-0597
- Acronym
- DRIVE-ID
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Imaging data will be de-identified and then shared with Eindhoven University of Technology for further analyses and modeling.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT06867887
- Acronym / sponsor ID
- DRIVE-ID / MEC-2023-0597
- Keywords
- Infection, LVAD, Detection, Monitoring, Driveline infection, Imaging, Non-invasive
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 26 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with an LVAD | – | – |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with an LVAD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
2 secondary outcomes
Sceptic complications
Time frame: 26 weeks
Machine learning model for predicting DLIs.
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Yes. Imaging data will be de-identified and then shared with Eindhoven University of Technology for further analyses and modeling.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
K. Caliskan, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LVAD (Left Ventricular Assist Device) Driveline Infection, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent and severity of driveline infections in LVAD patients using non-invasive imaging (time frame: 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.