EluPro Antibiotic-Eluting BioEnvelope Registry

Running, not enrolling

Conditions studied: Cardiac Arrhythmias

In brief

A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation

Key facts

Study ID

NCT06854081

Run by

Elutia Inc.

People needed

100

Starts

2025-04-17

Expected to finish

2026-12-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UC San Diego Health — La Jolla, California, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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