Infection after CIED implantation
Conditions
Interventions
The study intervention is the randomization and the placement of the TYRX
envelop with the (planned) CIED (re)placement in the testgroup.
Antibiotic
cardiovascular implantable devices
envelope
Sponsors
Medtronic Trading NL BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Patient is at least 18 years old - Patient is planned to undergo at least one of the following: a. Patient has existing CIED and is undergoing IPG (including CRT-D), ICD or CRT-D replacement or upgrade with a new Medtronic generator. i. Subjects planned to have leads added, or extracted and added for upgrades can be enrolled. OR b. Patient will undero a de novo Medtronic CRT-D system implant per approved indications OR c. Patient has an existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision.
Exclusion criteria
Exclusion criteria: - Known allergy to minocyclin or rifampin or their derivates, or any other known contraindications to implantation of the TYRX envelope - Current therapy with chronic oral immunosuppressive agents or >= 20 mg/day of Prednisone or equivalent. - Hemodialysis or peritoneal dialysis - Prior cardiac transplantation or existing ventricular assist device (VAD) - Require long-term vascular acces for any reason - Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months. - Physical, clinical, or laboratory signs or symptoms consistent with an active infection (including, but not limited to pneumonia, urinary tract, cellulitis, or bacteremia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objective is to compare the rate of major CIED infections through 12-months post-implant between the TYRX envelope group and the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives - Confirm that the TYRX envelope does not increase the CIED procedure-related or system-related complication rate through 12-months post-procedure. - Compare the major CIED infection rate during the entire follow-up between the TYRX envelope group and the control group. - Compare the rate of major and minor CIED infections through 12-months post-procedure between the TYRX envelope group and the control group. Ancillary objectives - Compare all-cause mortality rates between the TYRX envelope group and the control group - Evaluate the CIED procedure success rate in the TYRX envelope group and the control group • Control: device and leads all implanted • Treatment: TYRX envelope, device, and leads all implanted - Summarize the adverse events - Identify the predictors of CIED infection - Summarize quality of life - Evaluate the cost effectiveness of the TYRX envelope | — |
Countries
The Netherlands
Outcome results
None listed