NCT02277990

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7,075 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• CIED Related Infection

Interventions

Type	Name	Description
DEVICE	TYRX™ Absorbable Antibacterial Envelope

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2014-10-29
• Last updated: 2019-11-05
• Results posted: 2019-10-24

Locations

181 sites across 25 countries: United States, Austria, Belgium, Canada, Chile, China, Denmark, Finland, France, Germany, Greece, Israel, Italy, Malaysia, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study