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EluPro Antibiotic-Eluting BioEnvelope Registry | Clinical Trials | Clareo Health

RECRUITING

EluPro Antibiotic-Eluting BioEnvelope Registry

A Multi-Center Registry Evaluating EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation

NCT06854081•Elutia Inc.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

UC San Diego Health

La Jolla, California, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 17, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

June 17, 2025

Enrollment

100

ESTIMATED participants

Conditions

Cardiac Arrhythmias

Interventions

EluPro Antibiotic-Eluting BioEnvelope

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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EluPro Antibiotic-Eluting BioEnvelope Registry

Inclusion Criteria

Exclusion Criteria

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