A Multi-Center Registry Evaluating EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
Elutia Inc.
Summary
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
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 questio…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 s…
Interventions
- Combination ProductEluPro Antibiotic-Eluting BioEnvelope
Utilization of an EluPro Antibiotic-Eluting BioEnvelope with the CIED during the participant's CIED implant procedure.
Locations (4)
- UC San Diego HealthLa Jolla, California
- Tallahassee Research InstituteTallahassee, Florida
- Brigham & Women's HospitalBoston, Massachusetts
- Penn Presbyterian Medical CenterPhiladelphia, Pennsylvania