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World-wide Randomized Antibiotic Envelope Infection Prevention Trial

NCT02277990 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7075

Last updated 2019-11-05

Study results available
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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

DEVICE

TYRX™ Absorbable Antibacterial Envelope

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Bruce Wilkoff, MD · The Cleveland Clinic

  • Khaldoun Tarakji, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Device
Yes

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02277990 on ClinicalTrials.gov