Cardiac Arrhythmias
Conditions
Keywords
EluPro, CIED, Envelope, Arrhythmia
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.
Interventions
COMBINATION_PRODUCTEluPro Antibiotic-Eluting BioEnvelope
Utilization of an EluPro Antibiotic-Eluting BioEnvelope with the CIED during the participant's CIED implant procedure.
Sponsors
Elutia Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed