Last updated on November 2017

World-wide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT)


Brief description of study

World-wide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT)

Detailed Study Description

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. The study has three purposes. First, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study to facilitate collection of complications related to the Cardiovascular Implantable Electronic Device (CIED) procedure or system in subjects randomized to receive the TYRXTM Absorbable Antibacterial Envelope (henceforth referred to as TYRX envelope). Next, this study will evaluate the ability of the TYRX envelope to reduce major CIED infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or the implant of a de novo CRT-D. Subjects undergoing CIED generator replacement, upgrade, revision or the implant of a de novo.

Subjects will be screened to ensure they meet all of the inclusion and none of the exclusion criteria. Subjects are considered enrolled in the study upon signing the PIC. Informed consent must be obtained prior to performing any of the study-related procedures. The complete informed consent process will include giving the subject adequate information about the study and ensuring that there is a sufficient amount of time to comprehend the information in the PIC and have all questions answered before making a decision to participate in the study and audio-video record the consent process when applicable per local laws and regulations.

Clinical Study Identifier: TX5272

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Melissa Shepherd

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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