Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT)

Area of Science:

• Cardiology
• Infectious Diseases
• Medical Devices

Background:

• Cardiac implantable electronic device (CIED) infections pose significant risks, leading to increased morbidity and mortality.
• Preventing CIED infections is crucial for improving patient outcomes and reducing healthcare burdens.

Purpose of the Study:

• To evaluate the efficacy of the Medtronic TYRX absorbable envelope in preventing CIED infections.
• To assess the cost-effectiveness of using the TYRX absorbable envelope.
• To gain insights into the pathophysiology and risk factors associated with CIED infections.

Main Methods:

• The WRAP-IT study is a large, randomized, prospective, multi-center, international, single-blinded trial.
• Enrollment of up to 7,764 subjects undergoing CIED procedures (replacement, upgrade, revision, or de novo CRT-D implant).
• Participants are randomized 1:1 to receive the TYRX envelope or standard care; primary endpoint is major CIED infection at 12 months.

Main Results:

• Primary endpoint: Major CIED infection rates at 12 months post-procedure.
• Secondary analysis: Performance of Medtronic's lead monitoring algorithms in specific CIED systems.

Conclusions:

• The WRAP-IT trial will provide robust data on the TYRX absorbable envelope's effectiveness in reducing CIED infections.
• Findings will inform clinical practice regarding infection prevention strategies for CIEDs.
• The study aims to enhance understanding of CIED infection mechanisms and identify key risk factors.