EluPro Antibiotic-Eluting BioEnvelope Registry

NCT06854081 | Recruiting FDA Device

• 1 other identifier: CPR-2404
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cardiac Arrhythmias

Keywords

EluPro; CIED; Envelope; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Adverse Events/Complication Rates

  Determine the rates of adverse events and complications associated with the use of EluPro device envelope in real-world settings.

  12 Months

Study Arms (1)

EluPro

EluPro Antibiotic-Eluting BioEnvelope

Combination Product: EluPro Antibiotic-Eluting BioEnvelope

Interventions

EluPro Antibiotic-Eluting BioEnvelope COMBINATION_PRODUCT

Utilization of an EluPro Antibiotic-Eluting BioEnvelope with the CIED during the participant's CIED implant procedure.

EluPro

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 100 participants who will receive a EluPro Antibiotic-Eluting BioEnvelope during their CIED procedure

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elutia Inc.: lead

Study Sites (4)

UC San Diego Health

La Jolla, California, 92037, United States

RECRUITING

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

RECRUITING

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)