EluPro Antibiotic-Eluting BioEnvelope Registry

Launched by ELUTIA INC. · Feb 25, 2025

Keywords

ClinConnect Summary

The EluPro Antibiotic-Eluting BioEnvelope Registry is a clinical trial that aims to study the use of a special device called the EluPro during heart device surgeries. This device helps prevent infections in patients who are getting new heart devices or replacing their old ones. The trial is currently looking for participants aged 18 and older who are having this procedure done and who agree to follow up with the study team.

To be eligible for this trial, patients should not have had any infections related to heart devices in the past year, and they should not show any signs of active infections. It's also important that individuals do not have serious kidney disease or certain allergies. Participants in the trial will receive the EluPro device and will be monitored during their recovery to see how well it works in preventing infections. This trial is an opportunity to help improve heart device surgeries and the safety of patients undergoing these procedures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.