NCT06854081 EluPro Antibiotic-Eluting BioEnvelope Registry
| NCT ID | NCT06854081 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elutia Inc. |
| Condition | Cardiac Arrhythmias |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-17 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
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 secu