Heart DiseasesNCT04299282
CIED Implantation in Low BMI Patients
A study testing CanGaroo in people with Heart Diseases and Cardiac Disease, run by Elutia Inc..
Trial summary
The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases, Cardiac Disease
- What is being tested?
- CanGaroo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI of less than 23.
- Already scheduled for or a clinical decision made to have one of the following qualifying CIED implant procedures using a device cleared by the U.S. FDA:
- De novo pacemaker, ICD, or S-ICD;
- Upgrade or change out of existing CIED to a pacemaker, ICD, or S-ICD
- Clinically stable and able to tolerate procedure.
- Be able and willing to return for follow-up care through the 3-month visit.
- Must possess the ability to provide informed consent.
Who cannot join
- Patients with a known sensitivity to porcine material.
- Participation in another clinical study.
- Active infection. Clinical diagnosis of an active infection at the time of CIED implant (CIED infection, pneumonia, UTI, endovascular, cellulitis, bacteremia, or other major systemic infection).
- Female patient who is pregnant, or planning to become pregnant during the length of the study.
- Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis in the past 12 months.
- Life expectancy of less than 3 months.
About this study
Official title: A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).
Read the detailed description
A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.
- Conditions
- Heart Diseases, Cardiac Disease
- Being tested
- CanGaroo
- Keywords
- CIED, Pacemaker, ICD, S-ICD
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanGarooDevice
CIED ECM envelope
| Study group | Role | What they receive |
|---|---|---|
| CanGaroo | Active comparator | The treatment group will receive a CanGaroo envelope with implantation of a CIED Receives: Device: CanGaroo |
| No CanGaroo | No intervention | The control group will not receive a CanGaroo envelope with implantation of a CIED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing at incision site
Improved incision site healing for the CanGaroo group
Measured: 3 months post CIED implantation
Secondary outcomes (3)
QOL Survey
Patient assessment via Quality of Life Survey
Measured: 3 months post CIED implantation
Vascular Tissue Layer
Ultrasound measurement of vascular tissue layer
Measured: 3 months post CIED implantation
Skin Fold Test
Skin fold test measurement for tissue thickness
Measured: 3 months post CIED implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study startJun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: Postponed due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerry Riebman, MD, MA, Study director, Elutia Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299282
- Sponsor's protocol ID
- CPR-2205
- Status last verified
- May 2025
- First submitted
- 5 Mar 2020
- Last updated
- 16 May 2025
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
- ClinicalTrials.gov ID
- NCT04299282
- Acronym / sponsor ID
- CPR-2205
- Conditions
- Heart Diseases, Cardiac Disease
- Keywords
- CIED, Pacemaker, ICD, S-ICD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Postponed due to COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 6 Mar 2020 (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.
The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).
Detailed description
A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled
| Arm | Type | Receives |
|---|---|---|
| CanGaroo | Active comparator | Device: CanGarooThe treatment group will receive a CanGaroo envelope with implantation of a CIED |
| No CanGaroo | No intervention | –The control group will not receive a CanGaroo envelope with implantation of a CIED |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- BMI of less than 23.
- Already scheduled for or a clinical decision made to have one of the following qualifying CIED implant procedures using a device cleared by the U.S. FDA:
- Clinically stable and able to tolerate procedure.
- Be able and willing to return for follow-up care through the 3-month visit.
- Must possess the ability to provide informed consent.
Key exclusion criteria (6 listed)
- Patients with a known sensitivity to porcine material.
- Participation in another clinical study.
- Active infection. Clinical diagnosis of an active infection at the time of CIED implant (CIED infection, pneumonia, UTI, endovascular, cellulitis, bacteremia, or other major systemic infection).
- Female patient who is pregnant, or planning to become pregnant during the length of the study.
- Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis in the past 12 months.
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 |
|---|---|---|
| CanGarooCIED ECM envelope | Device | CanGaroo |
Primary outcome
Healing at incision site
Time frame: 3 months post CIED implantation
Improved incision site healing for the CanGaroo group
3 secondary outcomes
QOL Survey
Time frame: 3 months post CIED implantation
Vascular Tissue Layer
Time frame: 3 months post CIED implantation
Skin Fold Test
Time frame: 3 months post CIED implantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Sponsor websiteLink provided by the sponsor.
- 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.
Jerry Riebman, MD, MA study director
Elutia Inc.
Questions about this trial
What is this clinical trial studying?
A study testing CanGaroo in people with Heart Diseases and Cardiac Disease, run by Elutia Inc..
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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Healing at incision site (time frame: 3 months post CIED implantation). 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 16 May 2025.