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
Neptune, New Jersey 07754
1284
mi
from
Neptune, NJ
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
from
Boston, MA
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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...
898
mi
from
Cleveland, OH
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New York, New York 10021
1289
mi
from
New York, NY
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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...
1121
mi
from
Rochester, NY
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
897
mi
from
Akron, OH
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899
mi
from
Akron, OH
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Allentown, Pennsylvania 18103
1207
mi
from
Allentown, PA
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Amarillo, Texas 79106
283
mi
from
Amarillo, TX
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Anchorage, Alaska 99508
2732
mi
from
Anchorage, AK
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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...
808
mi
from
Ann Arbor, MI
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Asheville, North Carolina
858
mi
from
Asheville, NC
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Atlantis, Florida 33462
1287
mi
from
Atlantis, FL
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Baltimore, Maryland 21237
1154
mi
from
Baltimore, MD
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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...
1145
mi
from
Baltimore, MD
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634
mi
from
Baton Rouge, LA
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Bethlehem, Pennsylvania 18015
1217
mi
from
Bethlehem, PA
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Burlington, Vermont 05405
1357
mi
from
Burlington, VT
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Charlotte, North Carolina 28204
958
mi
from
Charlotte, NC
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Chula Vista, California 91910
1139
mi
from
Chula Vista, CA
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Cincinnati, Ohio 45219
725
mi
from
Cincinnati, OH
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1100
mi
from
Clearwater, FL
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898
mi
from
Cleveland, OH
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700 Ironwood Drive
Coeur d'Alene, Idaho 83814
1177
mi
from
Coeur d'Alene, ID
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Colorado Springs, Colorado 80907
386
mi
from
Colorado Springs, CO
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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...
810
mi
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Columbus, OH
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810
mi
from
Columbus, OH
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Corpus Christi, Texas 78404
690
mi
from
Corpus Christi, TX
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348
mi
from
Dallas, TX
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Dallas, Texas 75231
341
mi
from
Dallas, TX
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Danbury, Connecticut 06810
1317
mi
from
Danbury, CT
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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...
1151
mi
from
Danville, PA
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Doylestown, Pennsylvania 18901
1227
mi
from
Doylestown, PA
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Durham, North Carolina 27710
1052
mi
from
Durham, NC
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East Providence, Rhode Island 02906
1424
mi
from
East Providence, RI
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
408
mi
from
Englewood, CO
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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...
1288
mi
from
Englewood, NJ
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Erie, Pennsylvania
Principal Investigator: Jean Moubarak
984
mi
from
Erie, PA
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Evanston, Illinois 60201
Principal Investigator: Westby Fisher
612
mi
from
Evanston, IL
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Fort Worth, Texas 76104
348
mi
from
Fort Worth, TX
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Fresno, California 93720
1207
mi
from
Fresno, CA
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Gainesville, Florida 32605
1045
mi
from
Gainesville, FL
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1049
mi
from
Gainesville, FL
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Germantown, Tennessee 38138
481
mi
from
Germantown, TN
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Green Bay, Wisconsin 54301
689
mi
from
Green Bay, WI
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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...
693
mi
from
Green Bay, WI
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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...
1358
mi
from
Hartford, CT
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Hattiesburg, Mississippi 39401
Principal Investigator: Randel Smith
659
mi
from
Hattiesburg, MS
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Huntington, West Virginia 25702
Principal Investigator: Aamir Cheema
836
mi
from
Huntington, WV
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Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
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Jackson, Tennessee 38301
520
mi
from
Jackson, TN
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196
mi
from
Kansas City, KS
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Kansas City, Missouri
198
mi
from
Kansas City, MO
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Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
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10 Mitterweg
Krems, 3500
5221
mi
from
Krems,
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La Jolla, California 92093
1142
mi
from
La Jolla, CA
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Lafayette, Colorado
Principal Investigator: Kelly Kim
420
mi
from
Lafayette, CO
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Lansing, Michigan 48912
776
mi
from
Lansing, MI
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Lexington, Kentucky 40503
725
mi
from
Lexington, KY
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Liverpool, New York
Principal Investigator: Ali Al-Mudamgha
1190
mi
from
Liverpool, NY
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402
mi
from
Longview, TX
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Louisville, Kentucky 40205
Principal Investigator: Michael Springer
656
mi
from
Louisville, KY
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807
mi
from
Marquette, MI
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807
mi
from
Marquette, MI
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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...
600
mi
from
Maywood, IL
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1520 South Dobson Road
Mesa, Arizona 85202
844
mi
from
Mesa, AZ
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Minneapolis, Minnesota 55407
549
mi
from
Minneapolis, MN
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Minneapolis, Minnesota 55455
552
mi
from
Minneapolis, MN
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619
mi
from
Nashville, TN
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Nashville, Tennessee 37205
619
mi
from
Nashville, TN
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New Brunswick, New Jersey 08901
Principal Investigator: Amardeep (Deepak) Saluja
1263
mi
from
New Brunswick, NJ
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New York, New York
Principal Investigator: Emad Aziz
1286
mi
from
New York, NY
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New York, New York 10032
1290
mi
from
New York, NY
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NYU
New York, New York
1286
mi
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New York, NY
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Newtown, Pennsylvania 18940
1237
mi
from
Newtown, PA
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Oklahoma City, Oklahoma 73120
150
mi
from
Oklahoma City, OK
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158
mi
from
Oklahoma City, OK
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Omaha, Nebraska 68198
259
mi
from
Omaha, NE
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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...
1225
mi
from
Philadelphia, PA
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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,...
1225
mi
from
Philadelphia, PA
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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...
1225
mi
from
Philadelphia, PA
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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...
1225
mi
from
Philadelphia, PA
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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...
1223
mi
from
Philadelphia, PA
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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...
971
mi
from
Pittsburgh, PA
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974
mi
from
Pittsburgh, PA
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Plano, Texas 75093
330
mi
from
Plano, TX
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Poland, Ohio 44514
944
mi
from
Poland, OH
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Portland, Oregon
1383
mi
from
Portland, OR
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1384
mi
from
Portland, OR
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Portland, Oregon 97213
Principal Investigator: Randy Jones
1383
mi
from
Portland, OR
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Raleigh, North Carolina
1068
mi
from
Raleigh, NC
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Rancho Mirage, California 92270
1076
mi
from
Rancho Mirage, CA
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1113
mi
from
Richmond, VA
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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...
1281
mi
from
Ridgewood, NJ
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553
mi
from
Robbinsdale, MN
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Rochester, Minnesota 55905
Principal Investigator: Malini Madhavan
515
mi
from
Rochester, MN
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Royal Oak, Michigan 48314
847
mi
from
Royal Oak, MI
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1406 6th Avenue North
Saint Cloud, Minnesota 56303
572
mi
from
Saint Cloud, MN
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670
mi
from
Saint Joseph, MI
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Saint Louis, Missouri 63128
418
mi
from
Saint Louis, MO
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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...
414
mi
from
Saint Louis, MO
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