RECRUITING

EluPro Antibiotic-Eluting BioEnvelope Registry

Conditions

Cardiac Arrhythmias EluPro CIED Envelope Arrhythmia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation

Official Title

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

Quick Facts

Study Start:2025-04

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06854081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

UC San Diego Health

La Jolla, California, 92037

United States

Collaborators and Investigators

Sponsor: Elutia Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-04

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

EluPro
CIED
Envelope
Arrhythmia

Additional Relevant MeSH Terms

Cardiac Arrhythmias