EluPro Antibiotic-Eluting BioEnvelope Registry

Elutia Inc.

Status: Enrolling

Conditions: Cardiac Arrhythmias

Treatments: Combination Product: EluPro Antibiotic-Eluting BioEnvelope

Study type: Observational

Funder types: Industry

Identifiers

NCT06854081

CPR-2404

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

EluPro

Description:

EluPro Antibiotic-Eluting BioEnvelope

Treatment:

Combination Product: EluPro Antibiotic-Eluting BioEnvelope