Arrhythmias, CardiacNCT04846127
CanGaroo® Registry Study
An observational study of Arrhythmias, Cardiac, run by Elutia Inc. at 23 sites in United States.
Trial summary
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- CanGaroo Envelope
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 23 sitesUnited States
- Study dates
- 25 May 2021to 17 Oct 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 500 participants who will either receive a CanGaroo envelope or no envelope during their de novo cardiac implantable electronic device implantation.
Who may be able to join
- Participants for whom this is their first CIED implantation at a particular anatomical site.
- Participants with a history of prior CIED implants at other anatomical sites than the current site can be included, provided that the planned implant location for the current CIED procedure is the first implant procedure at that site.
- Participants aged 18 years or older at time of enrollment.
- Participant is able and agrees to provide written informed consent and use of PHI.
Who cannot join
- Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site.
- Participants under the age of 18 at time of enrollment.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Eastern Maine Medical Center
Bangor, Maine, 04401
Brigham & Women's Hospital, Cardiovascular Division
Boston, Massachusetts, 02115
Daytona Heart Group
Daytona Beach, Florida, 32114
The Arrhythmia Center of South Florida
Delray Beach, Florida, 33484
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale, Florida, 33308
VA Medical Center
Gainesville, Florida, 32607
University of Texas Medical Branch
Galveston, Texas, 77555
Houston Methodist
Houston, Texas, 77030
Cardiovascular Associates/Osceola Regional Medical Center
Kissimmee, Florida, 34741
Carolina Heart Specialists
Lancaster, South Carolina, 29720
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
St. Joseph Hospital
Lexington, Kentucky, 40504
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Baptist Health Floyd
New Albany, Indiana, 47150
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
UNC Health/NC Heart & Vascular Research
Raleigh, North Carolina, 27607
Ascension Providence Hospital
Southfield, Michigan, 48075
Advent Health
Tampa, Florida, 33613
Heart Rhythm Associates
The Woodlands, Texas, 77380
Mercy Health
Toledo, Ohio, 43608
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74127
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
Metro Health/University of Michigan Health
Wyoming, Michigan, 49519
About this study
Official title: A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation
Read the detailed description
This prospective, multi-center study will enroll up to 500 participants who are undergoing their initial CIED implant with either a CanGaroo envelope or no envelope.
Once a participant is enrolled in one of the two cohorts, each participant will have their medical history data reviewed and data will be recorded in the CRF including baseline demographics, medications, and diagnoses.
The details of the CIED procedure including any complications/AEs that occur during the procedure will be captured on the appropriate CRF.
Information collected at the follow-up visits will include documentation of post-procedure status, including any complications, adverse events, or revision/reoperation procedures that occur during the follow-up period. This information will also be collected for any unscheduled follow-ups, visits, or care encounters that occur up to 3 months post-procedure. For participants that agree and qualify for optional long-term follow-up, the same information will be collected at additional follow-up points every six months for up to five years.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- CanGaroo Envelope
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanGaroo EnvelopeDevice
Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.
| Study group | Role | What they receive |
|---|---|---|
| CanGaroo Envelope | Participants who receive a CanGaroo envelope during their CIED implant. Receives: Device: CanGaroo Envelope | |
| No Envelope | Participants who do not receive an envelope of any kind during their CIED implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between participant characteristics and outcomes
Cohort comparison of clinically significant factors such as physical and demographic characteristics, medical history risk factors related to post-procedure events, and associations with outcomes and events.
Measured: 3 months post-procedure
Association between CanGaroo envelope use and CIED implant-related outcomes and events.
Cohort comparison of clinically significant events such as infection, wound healing issues, CIED migration, CIED erosion, or a revision/reoperation procedure.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start25 May 2021
- Primary completion17 Apr 2023
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- 500 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas F. Deering, MD, Principal investigator, Piedmont Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846127
- Sponsor's protocol ID
- CPR-2218
- Status last verified
- May 2025
- First submitted
- 12 Apr 2021
- Last updated
- 15 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 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation
- ClinicalTrials.gov ID
- NCT04846127
- Acronym / sponsor ID
- CPR-2218
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 15 Apr 2021 (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 Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation
Detailed description
This prospective, multi-center study will enroll up to 500 participants who are undergoing their initial CIED implant with either a CanGaroo envelope or no envelope.
Once a participant is enrolled in one of the two cohorts, each participant will have their medical history data reviewed and data will be recorded in the CRF including baseline demographics, medications, and diagnoses.
The details of the CIED procedure including any complications/AEs that occur during the procedure will be captured on the appropriate CRF.
Information collected at the follow-up visits will include documentation of post-procedure status, including any complications, adverse events, or revision/reoperation procedures that occur during the follow-up period. This information will also be collected for any unscheduled follow-ups, visits, or care encounters that occur up to 3 months post-procedure. For participants that agree and qualify for optional long-term follow-up, the same information will be collected at additional follow-up points every six months for up to five years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CanGaroo Envelope | – | Device: CanGaroo EnvelopeParticipants who receive a CanGaroo envelope during their CIED implant. |
| No Envelope | – | –Participants who do not receive an envelope of any kind during their CIED implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 500 participants who will either receive a CanGaroo envelope or no envelope during their de novo cardiac implantable electronic device implantation.
Key inclusion criteria (4 listed)
- Participants for whom this is their first CIED implantation at a particular anatomical site.
- Participants with a history of prior CIED implants at other anatomical sites than the current site can be included, provided that the planned implant location for the current CIED procedure is the first implant procedure at that site.
- Participants aged 18 years or older at time of enrollment.
- Participant is able and agrees to provide written informed consent and use of PHI.
Key exclusion criteria (2 listed)
- Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site.
- Participants under the age of 18 at time of enrollment.
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 |
|---|---|---|
| CanGaroo EnvelopeUtilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure. | Device | CanGaroo Envelope |
Primary outcome
Association between participant characteristics and outcomes
Time frame: 3 months post-procedure
Cohort comparison of clinically significant factors such as physical and demographic characteristics, medical history risk factors related to post-procedure events, and associations with outcomes and events.
Association between CanGaroo envelope use and CIED implant-related outcomes and events.
Time frame: 3 months post-procedure
Cohort comparison of clinically significant events such as infection, wound healing issues, CIED migration, CIED erosion, or a revision/reoperation procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Aziyo Biologics, Inc. 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.
Thomas F. Deering, MD principal investigator
Piedmont Heart Institute
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Elutia Inc. at 23 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 2 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: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association between participant characteristics and outcomes (time frame: 3 months post-procedure). The study lists 2 primary outcomes in all. 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 15 May 2025.