EluPro Antibiotic-Eluting BioEnvelope Registry
Purpose
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
Condition
- Cardiac Arrhythmias
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| EluPro | EluPro Antibiotic-Eluting BioEnvelope |
|
Recruiting Locations
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Elutia Inc.
Study Contact
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.