NCT04645173

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

A Multi-Center Study Evaluating Participants Who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Elutia Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	CIED envelope	Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.

Timeline

• Start date: 2021-02-02
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2020-11-27
• Last updated: 2024-01-09

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study