Actively Recruiting
EluPro Antibiotic-Eluting BioEnvelope Registry
Led by Elutia Inc. · Updated on 2025-06-17
100
Participants Needed
4
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
CONDITIONS
Official Title
EluPro Antibiotic-Eluting BioEnvelope Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
2
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Actively Recruiting
3
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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