WRAP-IT Study Version 1.0 29 July 2014
Research type
Research Study
Full title
World-wide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT)
IRAS ID
170151
Contact name
Katrien Vandersteegen
Contact email
Sponsor organisation
Medtronic Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
The aim of this study is to evaluate the TYRX envelope a in subjects undergoing Cardiac Implantable Electronic Device (CIED, such as a pacemaker, a defibrillator or a cardiac resynchronization therapy device (CRT)) generator replacement, upgrade or revision or subjects that require a new (de novo) cardiac resynchronization therapy defibrillator (CRT-D). Subjects will be randomised to either have their CIED implanted inside the Medtronic TYRX envelope, an absorbable antibacterial pouch, or have their CIED implanted without the TYRX envelope. The purpose of the study is three-fold: firstly to fulfil post-approval requirements to facilitate collection of complications related to CIED procedure or system in subjects receiving the TYRX envelope. . Secondly, to evaluate the ability of the TYRX envelope to reduce major CIED infections within the first 12 months following CIED procedure. Thirdly, to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous RV defibrillation lead. This is a world-wide study involving up to 225 sites with up to 7,764 subjects enrolled in order to randomise approximately 6,988 subjects. Randomisation will be 1:1 and be stratified by study site and device type, high power versus low power devices. Subjects receiving a low power device will be capped at approximately 25% of the total study population as relative to high power device recipients, subjects receiving a low power device may be at reduced risk of a major CIED infection. Thus, to ensure an adequate CIED infection event rate in the control arm, there is a desire to include a higher proportion of high power devices in the trial.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0229
Date of REC Opinion
12 May 2015
REC opinion
Further Information Favourable Opinion