World-wide Randomized Antibiotic Envelope Infection Prevention Trial



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:12/7/2018
Start Date:January 2015
End Date:September 2018

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Cardiovascular 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 CIED infections through 12-months post-procedure following CIED
generator replacement, upgrade, revision, or de novo 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 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.


Inclusion Criteria:

- Patient is willing to sign and date the study 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 CIED and is undergoing IPG (including CRT-P), ICD or 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.
We found this trial at
121
sites
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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New York, New York 10021
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Allentown, Pennsylvania 18103
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Amarillo, Texas 79106
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Anchorage, Alaska 99508
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Asheville, North Carolina
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Atlantis, Florida 33462
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Baltimore, Maryland 21237
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Bethlehem, Pennsylvania 18015
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Burlington, Vermont 05405
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Charlotte, North Carolina 28204
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Chula Vista, California 91910
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Cincinnati, Ohio 45219
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Clearwater, FL
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700 Ironwood Drive
Coeur d'Alene, Idaho 83814
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Colorado Springs, Colorado 80907
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Corpus Christi, Texas 78404
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Dallas, Texas 75231
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Danbury, Connecticut 06810
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Doylestown, Pennsylvania 18901
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Durham, North Carolina 27710
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East Providence, Rhode Island 02906
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Erie, Pennsylvania
Principal Investigator: Jean Moubarak
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Evanston, Illinois 60201
Principal Investigator: Westby Fisher
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Fort Worth, Texas 76104
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Fresno, California 93720
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Gainesville, Florida 32605
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Germantown, Tennessee 38138
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Green Bay, Wisconsin 54301
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
(920) 288-8000
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hattiesburg, Mississippi 39401
Principal Investigator: Randel Smith
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Huntington, West Virginia 25702
Principal Investigator: Aamir Cheema
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Indianapolis, Indiana 46260
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Jackson, Tennessee 38301
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Kansas City, Missouri
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Kingsport, Tennessee 37660
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10 Mitterweg
Krems, 3500
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La Jolla, California 92093
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Lafayette, Colorado
Principal Investigator: Kelly Kim
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Lansing, Michigan 48912
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Lexington, Kentucky 40503
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Liverpool, New York
Principal Investigator: Ali Al-Mudamgha
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Louisville, Kentucky 40205
Principal Investigator: Michael Springer
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1520 South Dobson Road
Mesa, Arizona 85202
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Minneapolis, Minnesota 55407
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Minneapolis, Minnesota 55455
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Nashville, Tennessee 37205
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Neptune, New Jersey 07754
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New Brunswick, New Jersey 08901
Principal Investigator: Amardeep (Deepak) Saluja
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New York, New York
Principal Investigator: Emad Aziz
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New York, New York 10032
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NYU
New York, New York
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Newtown, Pennsylvania 18940
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Oklahoma City, Oklahoma 73120
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Omaha, Nebraska 68198
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Principal Investigator: Jeffrey Luebbert
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Principal Investigator: Joshua Cooper
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Plano, Texas 75093
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Poland, Ohio 44514
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Portland, Oregon
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Portland, Oregon 97213
Principal Investigator: Randy Jones
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Raleigh, North Carolina
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Rancho Mirage, California 92270
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223 N Van Dien Ave
Ridgewood, New Jersey 07450
(201) 447-8000
The Valley Hospital The Valley Hospital is a fully accredited, acute care, not-for-profit hospital serving...
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Rochester, Minnesota 55905
Principal Investigator: Malini Madhavan
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Royal Oak, Michigan 48314
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
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Saint Louis, Missouri 63128
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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