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

Use our guide to learn which trials are right for you!

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
Fresno, California 93720
1990
mi
from 43215
Fresno, CA
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
129
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
New York, New York 10021
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
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...
354
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
108
mi
from 43215
Akron, OH
Click here to add this to my saved trials
110
mi
from 43215
Akron, OH
Click here to add this to my saved trials
Allentown, Pennsylvania 18103
397
mi
from 43215
Allentown, PA
Click here to add this to my saved trials
Amarillo, Texas 79106
1078
mi
from 43215
Amarillo, TX
Click here to add this to my saved trials
Anchorage, Alaska 99508
3101
mi
from 43215
Anchorage, AK
Click here to add this to my saved trials
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...
164
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina
303
mi
from 43215
Asheville, NC
Click here to add this to my saved trials
Atlantis, Florida 33462
939
mi
from 43215
Atlantis, FL
Click here to add this to my saved trials
Baltimore, Maryland 21237
349
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
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...
340
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
803
mi
from 43215
Baton Rouge, LA
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
407
mi
from 43215
Bethlehem, PA
Click here to add this to my saved trials
Burlington, Vermont 05405
591
mi
from 43215
Burlington, VT
Click here to add this to my saved trials
Charlotte, North Carolina 28204
349
mi
from 43215
Charlotte, NC
Click here to add this to my saved trials
Chula Vista, California 91910
1948
mi
from 43215
Chula Vista, CA
Click here to add this to my saved trials
Cincinnati, Ohio 45219
98
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
829
mi
from 43215
Clearwater, FL
Click here to add this to my saved trials
138
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
700 Ironwood Drive
Coeur d'Alene, Idaho 83814
1749
mi
from 43215
Coeur d'Alene, ID
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
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...
2
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
5
mi
from 43215
Columbus, OH
Click here to add this to my saved trials
Corpus Christi, Texas 78404
1175
mi
from 43215
Corpus Christi, TX
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
510
mi
from 43215
Danbury, CT
Click here to add this to my saved trials
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...
344
mi
from 43215
Danville, PA
Click here to add this to my saved trials
Doylestown, Pennsylvania 18901
417
mi
from 43215
Doylestown, PA
Click here to add this to my saved trials
Durham, North Carolina 27710
352
mi
from 43215
Durham, NC
Click here to add this to my saved trials
East Providence, Rhode Island 02906
620
mi
from 43215
East Providence, RI
Click here to add this to my saved trials
501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
1163
mi
from 43215
Englewood, CO
Click here to add this to my saved trials
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...
479
mi
from 43215
Englewood, NJ
Click here to add this to my saved trials
Erie, Pennsylvania
Principal Investigator: Jean Moubarak
213
mi
from 43215
Erie, PA
Click here to add this to my saved trials
Evanston, Illinois 60201
Principal Investigator: Westby Fisher
283
mi
from 43215
Evanston, IL
Click here to add this to my saved trials
Fort Worth, Texas 76104
937
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
Gainesville, Florida 32605
712
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
713
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
Germantown, Tennessee 38138
501
mi
from 43215
Germantown, TN
Click here to add this to my saved trials
Green Bay, Wisconsin 54301
403
mi
from 43215
Green Bay, WI
Click here to add this to my saved trials
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...
400
mi
from 43215
Green Bay, WI
Click here to add this to my saved trials
80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
554
mi
from 43215
Hartford, CT
Click here to add this to my saved trials
Hattiesburg, Mississippi 39401
Principal Investigator: Randel Smith
694
mi
from 43215
Hattiesburg, MS
Click here to add this to my saved trials
Huntington, West Virginia 25702
Principal Investigator: Aamir Cheema
111
mi
from 43215
Huntington, WV
Click here to add this to my saved trials
Indianapolis, Indiana 46260
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
Jackson, Tennessee 38301
436
mi
from 43215
Jackson, TN
Click here to add this to my saved trials
620
mi
from 43215
Kansas City, KS
Click here to add this to my saved trials
Kansas City, Missouri
618
mi
from 43215
Kansas City, MO
Click here to add this to my saved trials
Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
Click here to add this to my saved trials
10 Mitterweg
Krems, 3500
4571
mi
from 43215
Krems,
Click here to add this to my saved trials
La Jolla, California 92093
1950
mi
from 43215
La Jolla, CA
Click here to add this to my saved trials
Lafayette, Colorado
Principal Investigator: Kelly Kim
1165
mi
from 43215
Lafayette, CO
Click here to add this to my saved trials
Lansing, Michigan 48912
207
mi
from 43215
Lansing, MI
Click here to add this to my saved trials
Lexington, Kentucky 40503
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
Liverpool, New York
Principal Investigator: Ali Al-Mudamgha
413
mi
from 43215
Liverpool, NY
Click here to add this to my saved trials
830
mi
from 43215
Longview, TX
Click here to add this to my saved trials
Louisville, Kentucky 40205
Principal Investigator: Michael Springer
188
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
504
mi
from 43215
Marquette, MI
Click here to add this to my saved trials
504
mi
from 43215
Marquette, MI
Click here to add this to my saved trials
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...
283
mi
from 43215
Maywood, IL
Click here to add this to my saved trials
1520 South Dobson Road
Mesa, Arizona 85202
1654
mi
from 43215
Mesa, AZ
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
623
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
623
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
332
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37205
332
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
Neptune, New Jersey 07754
475
mi
from 43215
Neptune, NJ
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
Principal Investigator: Amardeep (Deepak) Saluja
453
mi
from 43215
New Brunswick, NJ
Click here to add this to my saved trials
New York, New York
Principal Investigator: Emad Aziz
477
mi
from 43215
New York, NY
Click here to add this to my saved trials
New York, New York 10032
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
NYU
New York, New York
477
mi
from 43215
New York, NY
Click here to add this to my saved trials
Newtown, Pennsylvania 18940
427
mi
from 43215
Newtown, PA
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73120
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
848
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68198
694
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
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...
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
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,...
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
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...
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
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...
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
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...
414
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
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...
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
165
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Plano, Texas 75093
901
mi
from 43215
Plano, TX
Click here to add this to my saved trials
Poland, Ohio 44514
146
mi
from 43215
Poland, OH
Click here to add this to my saved trials
Portland, Oregon
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
2027
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Portland, Oregon 97213
Principal Investigator: Randy Jones
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
Raleigh, North Carolina
375
mi
from 43215
Raleigh, NC
Click here to add this to my saved trials
Rancho Mirage, California 92270
1883
mi
from 43215
Rancho Mirage, CA
Click here to add this to my saved trials
344
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
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...
473
mi
from 43215
Ridgewood, NJ
Click here to add this to my saved trials
630
mi
from 43215
Robbinsdale, MN
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: Malini Madhavan
559
mi
from 43215
Rochester, MN
Click here to add this to my saved trials
Royal Oak, Michigan 48314
182
mi
from 43215
Royal Oak, MI
Click here to add this to my saved trials
1406 6th Avenue North
Saint Cloud, Minnesota 56303
684
mi
from 43215
Saint Cloud, MN
Click here to add this to my saved trials
232
mi
from 43215
Saint Joseph, MI
Click here to add this to my saved trials
Saint Louis, Missouri 63128
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
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...
397
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials