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