Cardiac DiseaseHEALNCT04645173
Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation
An observational study of Cardiac Disease, run by Elutia Inc. at 11 sites in United States.
Trial summary
The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- CIED envelope
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 11 sitesUnited States
- Study dates
- 2 Feb 2021to 31 Dec 2023
- 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: Participants who underwent one or more prior CIED implantation procedure at the current implant site utilizing CanGaroo®, TYRX™, or no envelope and are returning for a CIED change-out or revision procedure.
Who may be able to join
- Participants who previously underwent one or more prior CIED implantations utilizing a CanGaroo® envelope, TYRX™ envelope, or no envelope and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure.
- The following possible scenarios would be eligible for enrollment:
- One prior CIED Implant: i. No envelope ii. CanGaroo® envelope iii. TYRX™ envelope b. Multiple prior CIED Implants (envelope type should remain the same for each participant throughout their implant history): i. No envelope → no envelope ii. No envelope → CanGaroo® envelope iii. No envelope → TYRX™ envelope iv. CanGaroo® envelope → CanGaroo® envelope v. TYRX™ envelope → TYRX™ envelope vi. No envelope → CanGaroo® envelope → CanGaroo® envelope vii. No envelope → no envelope → CanGaroo® envelope viii. No envelope → TYRX™ envelope → TYRX™ envelope ix. No envelope → no envelope → TYRX™ envelope
- Participants aged 18 years or older at time of enrollment.
- Participant is able and agrees to provide written informed consent and use of PHI.
- Participants for whom prior CIED implant history information can be obtained.
Who cannot join
- Active infection involving the CIED implant site (clinical diagnosis of an active infection at the time of change-out/revision procedure).
- Participants under the age of 18 at time of enrollment.
- Participants with a history of multiple prior CIED implants over time using more than one type of envelope will be excluded as well as participants with a history of one type of envelope use, but the current pocket does not have an envelope. Scenarios that would be excluded:
- CanGaroo® envelope → TYRX™ envelope
- TYRX™ envelope → CanGaroo® envelope
- CanGaroo® envelope - no envelope
Show all 18Show fewer
- TYRX™ envelope → no envelope
- No envelope → CanGaroo® envelope → no envelope
- No envelope → TYRX™ envelope → no envelope
- No envelope → CanGaroo® envelope → TYRX™ envelope
- No envelope → TYRX™ envelope → CanGaroo® envelope
- CanGaroo® envelope → no envelope → TYRX™ envelope
- TYRX™ envelope → no envelope → CanGaroo® envelope
- CanGaroo® envelope → TYRX™ envelope → no envelope
- TYRX™ envelope → CanGaroo® envelope → no envelope
- CanGaroo® envelope → CanGaroo® envelope → no envelope
- TYRX™ envelope → TYRX™ envelope → no envelope
- Participants undergoing a change-out or revision procedure less than 4 months from their prior procedure.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Bay Pines VA
Bay Pines, Florida, 33744
Valley Heart Rhythm Specialists
Chandler, Arizona, 85224
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Atrium Health
Concord, North Carolina, 28025
East Carolina University/Vidant Medical Center
Greenville, North Carolina, 27834
Baptist Medical Center
Jacksonville, Florida, 32207
University of Florida
Jacksonville, Florida, 32209
U of L Health/Jewish Hospital
Louisville, Kentucky, 40241
Columbia University Irving Medical Center
New York, New York, 10032
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Prairie Education & Research Cooperative / St. John's Hospital
Springfield, Illinois, 62769
About this study
Official title: A Multi-Center Study Evaluating Participants Who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation
The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.
Read the detailed description
This multi-center study will enroll up to approximately 100 participants who have undergone one or more implantations of a CIED with either CanGaroo®, TYRX™, or no envelope (up to approximately 30-35 participants per cohort) and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure.
Once enrolled, each participant will have their medical history data collected (baseline demographics, medical history, prior CIED exchanges/revisions, and post implant clinical events). Prior to the scheduled change-out/revision procedure, there will be an assessment of the current healed implant site skin incision independently by both the participant and investigator using the Patient and Observer Scar Assessment Scale (POSAS), as well as photographs taken of the current skin scar.
During the change-out/revision procedure, additional investigator assessments will include photographic documentation of CIED implant pocket lining, classification of the extent of lead adhesions in the implant pocket, and biopsies of the anterior and posterior capsule walls for histologic analysis. Procedural details and any complications/AEs that occur during the change-out/revision procedure will also be captured.
- Conditions
- Cardiac Disease
- Being tested
- CIED envelope
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIED envelopeDevice
Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.
| Study group | Role | What they receive |
|---|---|---|
| CanGaroo Envelope | Participants who received a CanGaroo envelope during CIED implantation Receives: Device: CIED envelope | |
| TYRX Envelope | Participants who received a TYRX envelope during CIED implantation Receives: Device: CIED envelope | |
| No Envelope | Participants who did not receive an envelope during CIED implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall
Microscopic analysis of cellularity, vascularity, collagen density, necrosis, infectious agents, remnant device material, giant cells, and fibrotic capsule thickness will be evaluated for each biopsy site using a quantitative scoring system with an attempt to distinguish between remnant envelope collagen (if ECM envelope was used) and neocollagen from the participant. Composite (total) and average scores will be determined based on the individual scores from each biopsy site. The quantitative thickness of each fibrotic capsule biopsy will be measured using digital image software. Four (4) thickness measurements will be performed across the image for each biopsy sample, and the average fibrotic thickness will be reported for each sample. In addition, the total average thickness across the four samples will be determined based on the average individual recordings.
Measured: Surgical Procedure Visit
Secondary outcomes (1)
Documented CIED Complications
Comparison between cohorts of documented clinical outcomes and complications since the most recent CIED procedure through the current change-out/revision procedure. Assessment of the clinical outcomes \& events of the 3 cohorts will inform on potential differences in clinical outcomes that may be related to the cohort treatment. For example: infection, Twiddler's syndrome, CIED migration, CIED erosion, lead revision, lead dislodgement, pocket revision, device reprogramming, pocket revision.
Measured: Pre-Surgery Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start2 Feb 2021
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elutia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645173
- Sponsor's protocol ID
- CPR-2214
- Acronym
- HEAL
- Status last verified
- Jan 2024
- First submitted
- 16 Nov 2020
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study Evaluating Participants Who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation
- ClinicalTrials.gov ID
- NCT04645173
- Acronym / sponsor ID
- HEAL / CPR-2214
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Elutia Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Nov 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 objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.
Detailed description
This multi-center study will enroll up to approximately 100 participants who have undergone one or more implantations of a CIED with either CanGaroo®, TYRX™, or no envelope (up to approximately 30-35 participants per cohort) and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure.
Once enrolled, each participant will have their medical history data collected (baseline demographics, medical history, prior CIED exchanges/revisions, and post implant clinical events). Prior to the scheduled change-out/revision procedure, there will be an assessment of the current healed implant site skin incision independently by both the participant and investigator using the Patient and Observer Scar Assessment Scale (POSAS), as well as photographs taken of the current skin scar.
During the change-out/revision procedure, additional investigator assessments will include photographic documentation of CIED implant pocket lining, classification of the extent of lead adhesions in the implant pocket, and biopsies of the anterior and posterior capsule walls for histologic analysis. Procedural details and any complications/AEs that occur during the change-out/revision procedure will also be captured.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CanGaroo Envelope | – | Device: CIED envelopeParticipants who received a CanGaroo envelope during CIED implantation |
| TYRX Envelope | – | Device: CIED envelopeParticipants who received a TYRX envelope during CIED implantation |
| No Envelope | – | –Participants who did not receive an envelope during CIED implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent one or more prior CIED implantation procedure at the current implant site utilizing CanGaroo®, TYRX™, or no envelope and are returning for a CIED change-out or revision procedure.
Key inclusion criteria (6 listed)
- Participants who previously underwent one or more prior CIED implantations utilizing a CanGaroo® envelope, TYRX™ envelope, or no envelope and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure.
- The following possible scenarios would be eligible for enrollment:
- Participants aged 18 years or older at time of enrollment.
- Participant is able and agrees to provide written informed consent and use of PHI.
- Participants for whom prior CIED implant history information can be obtained.
Key exclusion criteria (18 listed)
- Active infection involving the CIED implant site (clinical diagnosis of an active infection at the time of change-out/revision procedure).
- Participants under the age of 18 at time of enrollment.
- Participants with a history of multiple prior CIED implants over time using more than one type of envelope will be excluded as well as participants with a history of one type of envelope use, but the current pocket does not have an envelope. Scenarios that would be excluded:
- Participants undergoing a change-out or revision procedure less than 4 months from their prior procedure.
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 |
|---|---|---|
| CIED envelopeEvaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications. | Device | CanGaroo Envelope, TYRX Envelope |
Primary outcome
Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall
Time frame: Surgical Procedure Visit
Microscopic analysis of cellularity, vascularity, collagen density, necrosis, infectious agents, remnant device material, giant cells, and fibrotic capsule thickness will be evaluated for each biopsy site using a quantitative scoring system with an attempt to distinguish between remnant envelope collagen (if ECM envelope was used) and neocollagen from the participant. Composite (total) and average scores will be determined based on the individual scores from each biopsy site. The quantitative thickness of each fibrotic capsule biopsy will be measured using digital image software. Four (4) thickness measurements will be performed across the image for each biopsy sample, and the average fibrotic thickness will be reported for each sample. In addition, the total average thickness across the four samples will be determined based on the average individual recordings.
1 secondary outcome
Documented CIED Complications
Time frame: Pre-Surgery Visit
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 9 Jan 2024.
- Aziyo Biologics, Inc.Link 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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 Disease, run by Elutia Inc. at 11 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 6 inclusion and 18 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall (time frame: Surgical Procedure Visit). 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 9 Jan 2024.