Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation (HEAL)

Aziyo Biologics

Status: Completed

Conditions: Cardiac Disease

Treatments: Device: CIED envelope

Study type: Observational

Funder types: Industry

Identifiers

NCT04645173

CPR-2214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

46 participants in 3 patient groups

CanGaroo Envelope

Description:

Participants who received a CanGaroo envelope during CIED implantation

Treatment:

Device: CIED envelope

TYRX Envelope

Description:

Participants who received a TYRX envelope during CIED implantation

Treatment:

Device: CIED envelope

No Envelope

Description:

Participants who did not receive an envelope during CIED implantation