EluPro Registry
Evaluating the Use of Investigational BioEnvelope in CIED Implantation
Brief description of study
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Cardiac Arrhythmias
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Age: 18 years or above
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Gender: All
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.
This study investigates the use of an investigational antibiotic-eluting bioenvelope during cardiac implantable electronic device (CIED) procedures. The purpose of this study is to gather data from participants who receive this bioenvelope during their CIED implantation or replacement.
The study focuses on evaluating the safety and effectiveness of the antibiotic-eluting bioenvelope. It will assess participant outcomes, such as pain at the implant site and overall satisfaction, through questionnaires administered during follow-up visits.
- Who can participate: Participants must be 18 years or older and undergoing CIED implantation or replacement with the investigational bioenvelope. They must agree to follow-up visits and provide informed consent.
- Study details: Participants will receive the investigational bioenvelope during their CIED procedure. Follow-up visits will include questionnaires about pain and satisfaction.
- Study timelines and visits: The study will last 12 months. The study requires visits at Screening/Enrollment, Surgical Procedure, Wound Check (2-4 Weeks), 3, 6, and 12 months post-surgery.
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