World-wide Randomized Antibiotic Envelope Infection Prevention Trial — WRAP-IT  

CIED Related Infection Clinical Trial

Official title: Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial

Status Completed

Clinical Trial Summary

Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• CIED Related Infection
• Communicable Diseases
• Infection

• NCT number: NCT02277990
• Study type: Interventional
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Completion date: September 2018