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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease
• Intervention / Treatment: Device: CIED 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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

• Study Contact: Name: Shawn L'Official; Phone Number: 512-585-1031; Email: slofficial@aziyo.com

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Valley Heart Rhythm Specialists
  • Florida
    • Bay Pines, Florida, United States, 33744
      • Bay Pines VA
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Jacksonville, Florida, United States, 32209
      • University of Florida
  • Illinois
    • Springfield, Illinois, United States, 62769
      • Prairie Education & Research Cooperative / St. John's Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • U of L Health/Jewish Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Atrium Health
    • Greenville, North Carolina, United States, 27834
      • East Carolina University/Vidant Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. 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.

2. 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

3. Participants aged 18 years or older at time of enrollment.
4. Participant is able and agrees to provide written informed consent and use of PHI.
5. Participants for whom prior CIED implant history information can be obtained.

Exclusion Criteria:

1. Active infection involving the CIED implant site (clinical diagnosis of an active infection at the time of change-out/revision procedure).
2. Participants under the age of 18 at time of enrollment.

3. 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:

   1. CanGaroo® envelope → TYRX™ envelope
   2. TYRX™ envelope → CanGaroo® envelope
   3. CanGaroo® envelope - no envelope
   4. TYRX™ envelope → no envelope
   5. No envelope → CanGaroo® envelope → no envelope
   6. No envelope → TYRX™ envelope → no envelope
   7. No envelope → CanGaroo® envelope → TYRX™ envelope
   8. No envelope → TYRX™ envelope → CanGaroo® envelope
   9. CanGaroo® envelope → no envelope → TYRX™ envelope
   10. TYRX™ envelope → no envelope → CanGaroo® envelope
   11. CanGaroo® envelope → TYRX™ envelope → no envelope
   12. TYRX™ envelope → CanGaroo® envelope → no envelope
   13. CanGaroo® envelope → CanGaroo® envelope → no envelope
   14. TYRX™ envelope → TYRX™ envelope → no envelope
4. 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

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CanGaroo Envelope; Participants who received a CanGaroo envelope during CIED implantation	Device: CIED envelope; 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	Device: CIED envelope; 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	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	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)	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
CIED Scar Photographs	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
CIED Implant Photographs	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.	Surgical Procedure Visit
Assessment of Lead Adhesions within the Implant Pocket	This observation should be made while the CIED device is mobilized and removed from within the implant pocket.; The classification system is based on two estimated factors:The amount of fibrosis by visual estimate (none/trivial, mild, moderate, or severe). NOTE: If calcification is present, the capsule should be classified as Class 3 (severe).; The estimate of the percentage of the lead coiled within the implant pocket that is adhered or trapped within the capsule wall (Class 0: none, Class 1: <30%, Class 2: 30%-60%, and Class 3: >60%).	Surgical Procedure Visit

Collaborators and Investigators

• Sponsor: Aziyo Biologics, Inc.

Publications and helpful links

Helpful Links

• Aziyo Biologics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CPR-2214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes