- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645173
Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation (HEAL)
A Multi-Center Study Evaluating Participants Who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Shawn L'Official
- Phone Number: 512-585-1031
- Email: slofficial@aziyo.com
Study Locations
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-
Arizona
-
Chandler, Arizona, United States, 85224
- Valley Heart Rhythm Specialists
-
-
Florida
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Bay Pines, Florida, United States, 33744
- Bay Pines VA
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Jacksonville, Florida, United States, 32207
- Baptist Medical Center
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Jacksonville, Florida, United States, 32209
- University of Florida
-
-
Illinois
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Springfield, Illinois, United States, 62769
- Prairie Education & Research Cooperative / St. John's Hospital
-
-
Kentucky
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Louisville, Kentucky, United States, 40241
- U of L Health/Jewish Hospital
-
-
New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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North Carolina
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Concord, North Carolina, United States, 28025
- Atrium Health
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Greenville, North Carolina, United States, 27834
- East Carolina University/Vidant Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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:
a. 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CanGaroo Envelope
Participants who received a CanGaroo envelope during CIED implantation
|
Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.
|
TYRX Envelope
Participants who received a TYRX envelope during CIED implantation
|
Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.
|
No Envelope
Participants who did not receive an envelope during CIED implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Surgical Procedure Visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Documented CIED Complications
Time Frame: Pre-Surgery Visit
|
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.
|
Pre-Surgery Visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: Pre-Surgery Visit
|
10-point score: Each item of the POSAS is rated on a 10-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e., normal pigmentation, no itching). Score 10 equals the largest difference from normal skin (i.e., the worst imaginable scar or sensation). Total score: The total score of both scales can be simply calculated by summing up the scores of each of the six items. The total score can range from 6 to 60. The overall opinion item is not included in the sum score. |
Pre-Surgery Visit
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CIED Scar Photographs
Time Frame: Pre-Surgery Visit
|
Comparison of photographs of the previous skin incision scar taken pre-surgery.
The visual differences in the skin incision scar appearance between the 3 cohorts may correlate with histologic findings and/or post-implant clinical outcomes or events.
|
Pre-Surgery Visit
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CIED Implant Photographs
Time Frame: Surgical Procedure Visit
|
Comparison of photographs of the previous CIED implant pocket interior taken intraoperatively.
The visual differences in interior capsule wall appearance between the 3 cohorts may correlate with histologic findings and/or post-implant clinical outcomes or events.
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Surgical Procedure Visit
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Assessment of Lead Adhesions within the Implant Pocket
Time Frame: Surgical Procedure Visit
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NOTE: If calcification is present, the capsule should be classified as Class 3 (severe).
|
Surgical Procedure Visit
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPR-2214
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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