TYRX™ Pocket Health Study
Objective
The purpose to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.
Eligibility
- Previously underwent a transvenous CIED implantation utilizing TYRX™ Absorbable Antibacterial Envelope and is returning for a CIED replacement procedure without planned addition of new or revision of existing leads at least 12 months from the prior CIED implant with use of TYRX™ Absorbable Antibacterial envelope (TYRX procedure of interest)
- Participants with history of one or two prior CIED implantation(s) at current implant site can be included, provided there was no invasive intervention to the pocket since the TYRX procedure of interest, defined by Exclusion Criteria #2
- Age is ≥ 18 years (or meets age requirements per local law) at time of enrollment
- Procedure information from participant's TYRX procedure of interest can be obtained
- Date of the TYRX procedure of interest
- Received a TYRX™ Absorbable Antibacterial Envelope during TYRX procedure of interest
- Provides signed and dated authorization and/or consent per institution and local requirements
- Willing and able to comply with the protocol
NCT ID
NCT05356546
