A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
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 Type
OBSERVATIONAL
Enrollment
100
Utilization of an EluPro Antibiotic-Eluting BioEnvelope with the CIED during the participant's CIED implant procedure.
UC San Diego Health
La Jolla, California, United States
RECRUITINGTallahassee Research Institute
Tallahassee, Florida, United States
RECRUITINGBrigham & Women's Hospital
Boston, Massachusetts, United States
RECRUITINGAdverse Events/Complication Rates
Determine the rates of adverse events and complications associated with the use of EluPro device envelope in real-world settings.
Time frame: 12 Months
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Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
RECRUITING