Registry for patients receiving EluPro Antibiotic-Eluting BioEnvelope during heart device implantation
A Multi-Center Registry Evaluating EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
This study looks at how well the EluPro Antibiotic-Eluting BioEnvelope works for patients getting heart devices, by tracking their recovery and experiences over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elutia Inc. Industry-sponsored |
| Drugs / interventions | Prednisone |
| Locations | 4 sites (La Jolla, California and 3 other locations) |
| Trial ID | NCT06854081 on ClinicalTrials.gov |
What this trial studies
This observational registry study aims to evaluate participants who receive the EluPro Antibiotic-Eluting BioEnvelope during the implantation of cardiac implantable electronic devices (CIED). Up to 100 participants will be enrolled, and their data will be collected at various time points, including the day of surgery and follow-up visits at 2-4 weeks, 3, 6, and 12 months post-surgery. Patient-reported outcomes, such as pain and satisfaction, will be assessed at each follow-up visit, which can be conducted via telephone or video if necessary.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing either a new CIED implantation or a replacement/upgrade of an existing CIED with the EluPro device.
Not a fit: Patients with a history of CIED infection or active infections, as well as those with severe kidney disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve outcomes for patients undergoing CIED implantation by reducing the risk of infection.
How similar studies have performed: While this approach is novel in the context of the EluPro device, similar antibiotic-eluting technologies have shown promise in reducing infection rates in other settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California and 3 other locations
- UC San Diego Health — La Jolla, California, United States (Recruiting)
- Tallahassee Research Institute — Tallahassee, Florida, United States (Recruiting)
- Brigham & Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.