WRAP-IT

STUDY IDENTIFIER:

WRAP-IT

CONDITION:

CIED Related Infection; Interventional; Pacemaker; Defibrillator

CONTACT INFO:

Tammy Haas   |   tammy.haas@allina.com   |   612-863-6226

DESCRIPTION:

The Medtronic TYRX™ Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.

CRITERIA LIST/ QUALIFICATIONS:

  • Patient is at least 18 years of age and meets age requirements per local law.
  • Patient has existing CIED and is undergoing ICD or CRT-D replacement or upgrade with a new Medtronic generator.
  • Patient will be having de novo (first-time) CRT-D system implant.
  • Patient has existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision.
  • Willing to provide the contact information for the physician who provides follow-up for his/her CIED.
  • Patient is willing to sign and date the Informed Consent Form.
  • Patient is willing to comply with scheduled follow-up and study-related activities.
 

INVESTIGATORS:

JoEllyn Moore, MD

SPONSORS:

Medtronic Cardiac Rhythm and Heart Failure

STATUS:

Open/Enrolling