Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New antibiotic pouch aims to stop infections in heart device patients

NCT ID NCT06854081

Disease control Sponsor: Elutia Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 100 adults who receive an EluPro antibiotic-eluting envelope during implantation of a heart device (like a pacemaker). The envelope slowly releases antibiotics to prevent infection. Researchers are monitoring complication rates in real-world use to see how safe and effective it is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EluPro Antibiotic-Eluting BioEnvelope (a mesh pouch that releases antibiotics around a heart device)
What this could lead to
If successful, this could show that the EluPro envelope helps prevent infections in people with implanted heart devices, leading to safer procedures.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the envelope works better than standard care. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiac arrhythmias are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac arrhythmias

Contacts and locations

Locations

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308, United States

  • UC San Diego Health

    La Jolla, California, 92037, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.