EluPro Antibiotic-Eluting BioEnvelope Registry

Recruiting

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT06854081
• Lead Sponsor: Elutia Inc.

Brief Summary

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

Detailed Description

This prospective, multi-center registry study will enroll up to 100 participants who will receive an EluPro Antibiotic-Eluting BioEnvelope during their CIED procedure.

Participant data will be captured at several time points: Screening/Enrollment, day of Surgical Procedure, and at Wound Check (2-4 Weeks) 3, 6, and 12 months post-surgery, as well as any unscheduled visits up to 12 months post-surgery. Any follow-up visit can be completed via telephone/video if the participant is not scheduled to be seen in the office. Patient-reported outcomes such as implant site pain and satisfaction questionnaires shall be administered to participants at each follow-up visit.

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-03-03
• Study Start: 2025-04-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-13
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events/Complication Rates	12 Months	Determine the rates of adverse events and complications associated with the use of EluPro device envelope in real-world settings.

Trial Locations

Locations (4)

Tallahassee Research Institute; 🇺🇸 Tallahassee, Florida, United States

Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

UC San Diego Health; 🇺🇸 La Jolla, California, United States