NCT06854081
EluPro Antibiotic-Eluting BioEnvelope Registry
Active, Not Recruiting
Not specifiedAges 18+ObservationalElutia Inc.
~100 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:EluPro Antibiotic-Eluting BioEnvelope
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events/Complication Rates
Measured over 12 Months
Conditions
Where it's being run
4 sites across 4 statesCalifornia1
Florida1
Massachusetts1
Pennsylvania1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Patient is undergoing implantation of EluPro with either a de novo CIED implantation or has an existing CIED and is undergoing CIED replacement or upgrade.
Patient is willing to comply with scheduled follow-up and study-related visits.
Patient is 18 years of age or older at the time of enrollment.
Patient agrees to provide written informed consent and use of PHI.
Exclusion
Patient has a prior history of CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
Patient is exhibiting signs or symptoms consistent with any type of active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia).
Patient has Stage 4 or 5 kidney disease (eGFR \<30 ml/min).
Patient requires long-term vascular access for any reason.
Patient is undergoing implantation of a CIED that does not fit completely into EluPro, preventing closure of the bioenvelope to secure the CIED.
Patient is currently on chronic immunosuppressive agents or ≥20mg/day of Prednisone or equivalent.
Patient has known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to the implantation of EluPro.
Patient is participating in another clinical study that could impact the outcome and documented pre-approval from the study sponsor has not been obtained.
Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure.
What this trial measures
- Adverse Events/Complication Rates12 Months
Determine the rates of adverse events and complications associated with the use of EluPro device envelope in real-world settings.