Cardiac ArrhythmiasNCT06854081
EluPro Antibiotic-Eluting BioEnvelope Registry
An observational study of Cardiac Arrhythmias, run by Elutia Inc. at 4 sites in United States.
Trial summary
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmias
- What is being tested?
- EluPro Antibiotic-Eluting BioEnvelope
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Apr 2025to Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 participants who will receive a EluPro Antibiotic-Eluting BioEnvelope during their CIED procedure
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
UC San Diego Health
La Jolla, California, 92037
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Tallahassee Research Institute
Tallahassee, Florida, 32308
About this study
Official title: A Multi-Center Registry Evaluating EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
Read the 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
- Being tested
- EluPro Antibiotic-Eluting BioEnvelope
- Keywords
- EluPro, CIED, Envelope, Arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EluPro Antibiotic-Eluting BioEnvelopeCombination product
Utilization of an EluPro Antibiotic-Eluting BioEnvelope with the CIED during the participant's CIED implant procedure.
| Study group | Role | What they receive |
|---|---|---|
| EluPro | EluPro Antibiotic-Eluting BioEnvelope Receives: Combination Product: EluPro Antibiotic-Eluting BioEnvelope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events/Complication Rates
Determine the rates of adverse events and complications associated with the use of EluPro device envelope in real-world settings.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start17 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854081
- Sponsor's protocol ID
- CPR-2404
- Status last verified
- May 2026
- First submitted
- 25 Feb 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Registry Evaluating EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
- ClinicalTrials.gov ID
- NCT06854081
- Acronym / sponsor ID
- CPR-2404
- Conditions
- Cardiac Arrhythmias
- Keywords
- EluPro, CIED, Envelope, Arrhythmia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EluPro | – | Combination Product: EluPro Antibiotic-Eluting BioEnvelopeEluPro Antibiotic-Eluting BioEnvelope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 participants who will receive a EluPro Antibiotic-Eluting BioEnvelope during their CIED procedure
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EluPro Antibiotic-Eluting BioEnvelopeUtilization of an EluPro Antibiotic-Eluting BioEnvelope with the CIED during the participant's CIED implant procedure. | Combination product | EluPro |
Primary outcome
Adverse Events/Complication Rates
Time frame: 12 Months
Determine the rates of adverse events and complications associated with the use of EluPro device envelope in real-world settings.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmias, run by Elutia Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events/Complication Rates (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.