Khaldoun G Tarakji1, Suneet Mittal2, Charles Kennergren3, Ralph Corey4, Jeanne Poole5, Kurt Stromberg6, Daniel R Lexcen6, Bruce L Wilkoff7. 1. Section of Electrophysiology and Pacing, Cleveland Clinic, Cleveland, OH. Electronic address: tarakjk@ccf.org. 2. The Arrhythmia Institute of Valley Health System, Manhattan, NY. 3. Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Göteborg, Sweden. 4. Duke Clinical Research Institute, Duke University, Durham, NC. 5. Division of Cardiology, University of Washington, Seattle, WA. 6. Medtronic, plc Mounds View, MN. 7. Section of Electrophysiology and Pacing, Cleveland Clinic, Cleveland, OH.
Abstract
BACKGROUND: Cardiac implantable electronic device (CIED) infection is a major complication that is associated with significant morbidity and mortality. The aim of this study is to determine whether Medtronic TYRX absorbable envelope reduces the risk of CIED infection through 12 months of follow-up post procedure. METHODS:WRAP-IT is a randomized, prospective, multi center, international, single-blinded study. Up to 7,764 subjects who are undergoing CIED generator replacement, upgrade, or revision, or a de novo CRT-D implant, will be enrolled and randomized (1:1) to receive the TYRX envelope or not. The primary endpoint is major CIED infection throughout 12 months of follow up after the procedure. Data will be analyzed with an intention to treat approach. WRAP-IT will also assess the performance of Medtronic's lead monitoring algorithms in subjects whose CIED includes a transvenous right ventricular defibrillation system. CONCLUSIONS:WRAP-IT is a large randomized clinical trial that will assess the efficacy of TYRX absorbable envelope in reducing CIED infection, define its cost effectiveness, and will also provide a unique opportunity to better understand the pathophysiology and risk factors for CIED infection.
RCT Entities:
BACKGROUND: Cardiac implantable electronic device (CIED) infection is a major complication that is associated with significant morbidity and mortality. The aim of this study is to determine whether Medtronic TYRX absorbable envelope reduces the risk of CIED infection through 12 months of follow-up post procedure. METHODS: WRAP-IT is a randomized, prospective, multi center, international, single-blinded study. Up to 7,764 subjects who are undergoing CIED generator replacement, upgrade, or revision, or a de novo CRT-D implant, will be enrolled and randomized (1:1) to receive the TYRX envelope or not. The primary endpoint is major CIED infection throughout 12 months of follow up after the procedure. Data will be analyzed with an intention to treat approach. WRAP-IT will also assess the performance of Medtronic's lead monitoring algorithms in subjects whose CIED includes a transvenous right ventricular defibrillation system. CONCLUSIONS: WRAP-IT is a large randomized clinical trial that will assess the efficacy of TYRX absorbable envelope in reducing CIED infection, define its cost effectiveness, and will also provide a unique opportunity to better understand the pathophysiology and risk factors for CIED infection.
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