Clinical trial NCT06854081: EluPro Antibiotic-Eluting BioEnvelope Registry
Official title: A Multi-Center Registry Evaluating EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrhythmias
Keywords: EluPro
CIED
Envelope
Arrhythmia
Lead sponsor: Elutia Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 100 participants who will receive a EluPro Antibiotic-Eluting BioEnvelope during their CIED procedure

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events/Complication Rates
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Health
state: California
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
References: