NCT06854081

EluPro Antibiotic-Eluting BioEnvelope Registry

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Elutia Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Arrhythmias

Interventions

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

Timeline

• Start date: 2025-04-17
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-03
• Last updated: 2025-06-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study