World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT)

October 23, 2019 updated by: Medtronic Cardiac Rhythm and Heart Failure

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7075

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Krems, Austria
        • Universitätsklinikum Krems
  • Belgium
      • Brussel, Belgium
        • Universitair Ziekenhuis Brussel
      • Genk, Belgium
        • Ziekenhuis Oost Limburg - Campus St.-Jan
      • Liège, Belgium
        • Centre Hospitalier Regional de la Citadelle
  • Canada
      • Quebec, Canada
        • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Saint Paul's Hospital (Vancouver BC)
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton General Hospital / Hamilton Health Sciences
      • Ottawa, Ontario, Canada
        • University of Ottawa Heart Institute
  • Chile
      • Santiago, Chile
        • Hospital San Juan de Dios
  • China
      • Hong Kong, China
        • Princess Margaret Hospital
      • Hong Kong, China
        • Grantham Hospital
  • Denmark
      • København, Denmark
        • Rigshospitalet
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Turku, Finland
        • Turun yliopistollinen keskussairaala
  • France
      • Lille, France
        • Centre Hospitalier Regional Universitaire de Lille
      • Marseille, France
        • Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Rouen Cedex 1, France
        • CHU Hôpiteaux de Rouen - Hôpital Charles Nicolle
      • Saint Priest en Jarez, France
        • Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
  • Germany
      • Bad Krozingen, Germany
        • Universitäts-Herz-Zentrum Freiburg - Bad Krozingen
      • Rostock, Germany
        • Universitatsmedizin Rostock
  • Greece
      • Heraklion, Greece
        • University General Hospital of Heraklion
      • Ioannina, Greece
        • University Hospital of Ioannina
      • Kallithea, Greece
        • Onassis Cardiac Surgery Center
  • Israel
      • Petah Tikva, Israel
        • Rabin Medical Center - Beilinson Hospital
      • Ramat Gan, Israel
        • Chaim Sheba Medical Center
  • Italy
      • Bologna, Italy
        • Policlinico Sant' Orsola - Malpighi
      • Brescia, Italy
        • Azienda Ospedaliera Spedali Civili di Brescia
      • Como, Italy
        • Presidio Ospedaliero Sant'Anna
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara - National Heart Institute
      • Kuala Lumpur, Malaysia
        • Universiti Malaya Medical Centre
    • Kedah
      • Alor Setar, Kedah, Malaysia
        • Hospital Sultanah Bahiyah
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis
  • Norway
      • Bergen, Norway
        • Helse Bergen HF - Haukeland Universitetssjukehus
  • Poland
      • Lublin, Poland
        • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
      • Poznań, Poland
        • Szpital Kliniczny Przemienienia Pańskiego
  • Portugal
      • Lisboa, Portugal
        • Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
      • Porto, Portugal
        • Centro Hospitalar do Porto
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Faisal Specialist Hospital & Research Center
  • Singapore
      • Singapore, Singapore
        • Changi General Hospital
      • Singapore, Singapore
        • National Heart Centre Singapore
  • Slovakia
      • Banska Bystrica, Slovakia
        • Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
      • Bratislava 37, Slovakia
        • Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
      • Kosice, Slovakia
        • Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Bellvitge
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
    • Cantabria
      • Santander, Cantabria, Spain
        • Hospital Marques de Valdecilla
  • Sweden
      • Goteborg, Sweden
        • Alingsas Lasarett
      • Goteborg, Sweden
        • Sahlgrenska Universitetssjukhuset
      • Stockholm, Sweden
        • Karolinska Universitetssjukhuset
      • Varberg, Sweden
        • Sjukhuset i Varberg
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
      • Lugano, Switzerland
        • Cardiocentro Ticino
      • St. Gallen, Switzerland
        • Kantonsspital St.Gallen
  • United Kingdom
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom
        • Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital
      • Manchester, United Kingdom
        • Central Manchester University Hospitals NHS - Manchester Royal Infirmary
      • Newcastle Upon Tyne, United Kingdom
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
  • United States
    • Alaska
      • Anchorage, Alaska, United States
        • Alaska Heart Institute
    • Arizona
      • Mesa, Arizona, United States
        • Tri-City Cardiology Consultants
      • Scottsdale, Arizona, United States
        • Arizona Arrhythmia Consultants
    • California
      • Chula Vista, California, United States
        • Chula Vista Cardiac Center
      • Fresno, California, United States
        • Cardiovascular Consultants Heart Center
      • La Jolla, California, United States
        • UCSD Medical Center
      • Rancho Mirage, California, United States
        • Eisenhower Desert Cardiology Center
      • San Francisco, California, United States
        • University of California San Francisco UCSF Medical Center
      • Stanford, California, United States
        • Stanford Hospital & Clinics
      • Stockton, California, United States
        • Saint Joseph's Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States
        • Penrose St. Francis Hospital
      • Englewood, Colorado, United States
        • Swedish Medical Center
      • Lafayette, Colorado, United States
        • SCL Physicians Heart Institute of Colorado
    • Connecticut
      • Danbury, Connecticut, United States
        • Danbury Hospital
      • Hartford, Connecticut, United States
        • Hartford Hospital
    • District of Columbia
      • Washington, District of Columbia, United States
        • MedStar Washington Hospital Center
    • Florida
      • Atlantis, Florida, United States
        • Florida Electrophysiology Associates
      • Clearwater, Florida, United States
        • Clearwater Cardiovascular & Interventional Consultants
      • Gainesville, Florida, United States
        • The Cardiac & Vascular Institute
      • Gainesville, Florida, United States
        • University of Florida Health Shands Hospital
    • Idaho
      • Coeur d'Alene, Idaho, United States
        • Kootenai Heart Clinics Northwest
    • Illinois
      • Evanston, Illinois, United States
        • Northshore University Health System
      • Maywood, Illinois, United States
        • Loyola University Medical Center
      • Springfield, Illinois, United States
        • Prairie Education & Research Cooperative (Springfield IL)
    • Indiana
      • Indianapolis, Indiana, United States
        • Saint Vincent Medical Group
    • Iowa
      • West Des Moines, Iowa, United States
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, United States
        • The University Kansas Medical Center Research Institute Inc
    • Kentucky
      • Lexington, Kentucky, United States
        • Lexington Cardiac Research Foundation
      • Louisville, Kentucky, United States
        • Norton Cardiovascular Associates
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Cardiovascular Research Foundation of Louisiana
      • Shreveport, Louisiana, United States
        • Advanced Cardiovascular Specialists
    • Maine
      • Scarborough, Maine, United States
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, United States
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States
        • MedStar Health Research Institute
      • Salisbury, Maryland, United States
        • Delmarva Heart Research Foundation Inc
    • Massachusetts
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan
      • Lansing, Michigan, United States
        • Sparrow Clinical Research Institute
      • Marquette, Michigan, United States
        • DLP Marquette Physicians Practices Inc
      • Marquette, Michigan, United States
        • Upper Michigan Cardiovascular Associates PC
      • Royal Oak, Michigan, United States
        • Beaumont Hospital - Royal Oak
      • Saint Joseph, Michigan, United States
        • Great Lakes Heart and Vascular Institute PC
    • Minnesota
      • Minneapolis, Minnesota, United States
        • University of Minnesota Medical Center
      • Minneapolis, Minnesota, United States
        • Minneapolis Heart Institute Foundation
      • Robbinsdale, Minnesota, United States
        • North Memorial Heart and Vascular Institute
      • Rochester, Minnesota, United States
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States
        • CentraCare Heart & Vascular Center
      • Saint Paul, Minnesota, United States
        • United Heart and Vascular Clinic
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • Hattiesburg Clinic/ Forrest General
    • Missouri
      • Kansas City, Missouri, United States
        • Mid America Heart Institute (MAHI)
      • Saint Louis, Missouri, United States
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States
        • Saint Anthonys Medical Center
      • Springfield, Missouri, United States
        • Mercy Hospital Springfield
    • Nebraska
      • Omaha, Nebraska, United States
        • University of Nebraska
    • New Jersey
      • Englewood, New Jersey, United States
        • Englewood Hospital & Medical Center
      • Neptune, New Jersey, United States
        • Jersey Shore University Medical Center
      • New Brunswick, New Jersey, United States
        • Robert Wood Johnson Medical School
      • Ridgewood, New Jersey, United States
        • The Valley Hospital
      • Voorhees, New Jersey, United States
        • Lourdes Cardiology Services
    • New York
      • Liverpool, New York, United States
        • Saint Joseph's Hospital Health Center
      • New York, New York, United States
        • Cornell University Medical Center
      • New York, New York, United States
        • NYU
      • New York, New York, United States
        • Mount Sinai Saint Luke's Hospital
      • New York, New York, United States
        • New York Presbyterian Hospital
      • Rochester, New York, United States
        • University of Rochester Medical Center
      • Valhalla, New York, United States
        • Westchester Medical Center
    • North Carolina
      • Asheville, North Carolina, United States
        • Asheville Cardiology Associate PA
      • Charlotte, North Carolina, United States
        • Novant Health Heart and Vascular Institute
      • Durham, North Carolina, United States
        • Duke University Medical Center (DUMC)
      • Raleigh, North Carolina, United States
        • Raleigh Cardiology Associates
      • Winston-Salem, North Carolina, United States
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States
        • Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital
    • Ohio
      • Akron, Ohio, United States
        • Akron General Medical Center
      • Akron, Ohio, United States
        • Northeast Ohio Cardiovascular Specialists
      • Cincinnati, Ohio, United States
        • The Lindner Research Center
      • Cleveland, Ohio, United States
        • Cleveland Clinic
      • Cleveland, Ohio, United States
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States
        • The Ohio State University
      • Columbus, Ohio, United States
        • OhioHealth Riverside Methodist Hospital
      • Poland, Ohio, United States
        • Saint Elizabeth Health Center
      • Westerville, Ohio, United States
        • Mount Carmel East
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Oklahoma Heart Hospital Research Foundation
      • Oklahoma City, Oklahoma, United States
        • University of Oklahoma Health Science Center (OUHSC)
      • Tulsa, Oklahoma, United States
        • Oklahoma Heart Institute
    • Oregon
      • Portland, Oregon, United States
        • Legacy Medical Group
      • Portland, Oregon, United States
        • Oregon Health & Science University Hospital
      • Portland, Oregon, United States
        • Providence Health & Services
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Lehigh Valley Hospital Cedar Crest
      • Bethlehem, Pennsylvania, United States
        • Saint Luke's Hospital
      • Danville, Pennsylvania, United States
        • Geisinger Medical Center
      • Doylestown, Pennsylvania, United States
        • Doylestown Cardiology Associates - VIAA
      • Erie, Pennsylvania, United States
        • University of Pittsburgh Medical Center UPMC Hamot
      • Newtown, Pennsylvania, United States
        • Saint Mary Medical Center (Langhorne PA)
      • Philadelphia, Pennsylvania, United States
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Drexel University College of Medicine
      • Philadelphia, Pennsylvania, United States
        • Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, United States
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States
        • University of Pittsburgh Medical Center UPMC Presbyterian
    • Rhode Island
      • East Providence, Rhode Island, United States
        • The Miriam Hospital
    • Tennessee
      • Germantown, Tennessee, United States
        • The Stern Cardiovascular Foundation
      • Jackson, Tennessee, United States
        • Jackson Clinic
      • Kingsport, Tennessee, United States
        • Wellmont CVA Heart Institute
      • Nashville, Tennessee, United States
        • Centennial Heart Cardiovascular Consultants LLC
      • Nashville, Tennessee, United States
        • Saint Thomas Research Institute
    • Texas
      • Amarillo, Texas, United States
        • Amarillo Heart Group
      • Corpus Christi, Texas, United States
        • Cardiology Associates of Corpus Christi
      • Dallas, Texas, United States
        • Baylor Heart & Vascular Hospital
      • Dallas, Texas, United States
        • North Texas Heart Center
      • Fort Worth, Texas, United States
        • Plaza Medical Center of Fort Worth
      • Longview, Texas, United States
        • Longview Regional Medical Center
      • Plano, Texas, United States
        • Baylor Research Institute
      • Temple, Texas, United States
        • Scott & White Health Science Ctr
      • The Woodlands, Texas, United States
        • EP Heart LLC
    • Vermont
      • Burlington, Vermont, United States
        • The University of Vermont Medical Center Inc
    • Virginia
      • Richmond, Virginia, United States
        • Virginia Commonwealth University Health System
    • West Virginia
      • Huntington, West Virginia, United States
        • Saint Mary's Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, United States
        • Bellin Memorial Hospital, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is willing to sign and date the study patient informed consent (PIC) form
  • Patient is at least 18 years of age and meets age requirements per local law

  • Patient is planned to undergo at least one of the following:

    a. Patient has existing cardiac implantable electronic device (CIED) and is undergoing implantable pulse generator (IPG) (including cardiac resynchronization therapy pacemaker [CRT-P]), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) replacement or upgrade with a new Medtronic generator

    i. Subjects planned to have leads added, or extracted and added for upgrades can be enrolled OR

    b. Patient will undergo a de novo Medtronic CRT-D system implant per approved indications

OR

c. Patient has existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision

  • Willing to provide the contact information for the physician who provides followup for his/her CIED
  • Willing and able to comply with scheduled follow-up and study related activities

Exclusion Criteria:

  • Known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to implantation of the TYRX envelope.
  • Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone or equivalent.
  • Hemodialysis or peritoneal dialysis.
  • Prior Cardiac transplantation or existing Ventricular Assist Device (VAD).
  • Require long-term vascular access for any reason.
  • Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
  • Physical, clinical, or laboratory signs or symptoms consistent with an active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia)
  • Systemic lupus erythematous, because minocycline has been reported to aggravate this condition
  • Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure
  • Participation in another study that may confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TYRX™ envelope
The Medtronic TYRX™ Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
Device: TYRX™ Absorbable Antibacterial Envelope
No Intervention: Control
No TYRX™ envelope, bare CIED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12 Month Kaplan-Meier Estimate of Major CIED Infection Rate
Time Frame: Implant to 12 months

CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis.

Major CIED infections are defined as a CIED infection resulting in one or more of the following:

  • CIED system removal
  • Any invasive procedure (e.g. pocket opened) without system removal
  • Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage
  • Death
Implant to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection
Time Frame: Implant to 12 months
Major CIED infections are defined above. Minor CIED infections are defined as CIED infections that do not meet the definition of a major CIED infection
Implant to 12 months
12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication
Time Frame: Implant to 12 months
  • A CIED system related event is defined as an adverse event related to the CIED system which includes the device, leads, implant tool(s), programmer, or TYRX envelope (if applicable)
  • A CIED procedure related event is defined as an adverse event that occurs due to any procedure related to the implantation or surgical modification of the system including the TYRX envelope (if applicable)
  • A procedure or system related complication is defined as an adverse event related to a CIED procedure or the CIED system that results in at least one of the following:

Death,Termination of significant device function, Invasive intervention
Implant to 12 months
Kaplan-Meier Estimate of a Major Infection Throughout Follow-up
Time Frame: Throughout study follow-up Kaplan-Meier Estimate is at 36 Months

CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis.

Major CIED infections are defined as a CIED infection resulting in one or more of the following:

  • CIED system removal
  • Any invasive procedure (e.g. pocket opened) without system removal
  • Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage
  • Death
Throughout study follow-up Kaplan-Meier Estimate is at 36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Collaborators

The Cleveland Clinic

Investigators

  • Study Chair: Bruce Wilkoff, MD, The Cleveland Clinic
  • Principal Investigator: Khaldoun Tarakji, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRAP-IT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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