World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT)
CIED Related Infection
About this trial
This is an interventional prevention trial for CIED Related Infection
Eligibility Criteria
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.
Sites / Locations
- Alaska Heart Institute
- Tri-City Cardiology Consultants
- Arizona Arrhythmia Consultants
- Chula Vista Cardiac Center
- Cardiovascular Consultants Heart Center
- UCSD Medical Center
- Eisenhower Desert Cardiology Center
- University of California San Francisco UCSF Medical Center
- Stanford Hospital & Clinics
- Saint Joseph's Medical Center
- Penrose St. Francis Hospital
- Swedish Medical Center
- SCL Physicians Heart Institute of Colorado
- Danbury Hospital
- Hartford Hospital
- MedStar Washington Hospital Center
- Florida Electrophysiology Associates
- Clearwater Cardiovascular & Interventional Consultants
- The Cardiac & Vascular Institute
- University of Florida Health Shands Hospital
- Kootenai Heart Clinics Northwest
- NorthShore University Health System
- Loyola University Medical Center
- Prairie Education & Research Cooperative (Springfield IL)
- Saint Vincent Medical Group
- Iowa Heart Center
- The University Kansas Medical Center Research Institute Inc
- Lexington Cardiac Research Foundation
- Norton Cardiovascular Associates
- Cardiovascular Research Foundation of Louisiana
- Advanced Cardiovascular Specialists
- Maine Medical Center
- MedStar Health Research Institute
- Sinai Hospital of Baltimore
- Delmarva Heart Research Foundation Inc
- Massachusetts General Hospital
- University of Michigan
- Sparrow Clinical Research Institute
- DLP Marquette Physicians Practices Inc
- Upper Michigan Cardiovascular Associates PC
- Beaumont Hospital - Royal Oak
- Great Lakes Heart and Vascular Institute PC
- Minneapolis Heart Institute Foundation
- University of Minnesota Medical Center
- North Memorial Heart and Vascular Institute
- Mayo Clinic
- CentraCare Heart & Vascular Center
- United Heart and Vascular Clinic
- Hattiesburg Clinic/ Forrest General
- Mid America Heart Institute (MAHI)
- Saint Anthonys Medical Center
- Washington University School of Medicine
- Mercy Hospital Springfield
- University of Nebraska
- Englewood Hospital & Medical Center
- Jersey Shore University Medical Center
- Robert Wood Johnson Medical School
- The Valley Hospital
- Lourdes Cardiology Services
- Saint Joseph's Hospital Health Center
- Cornell University Medical Center
- Mount Sinai Saint Luke's Hospital
- New York Presbyterian Hospital
- NYU
- University of Rochester Medical Center
- Westchester Medical Center
- Asheville Cardiology Associate PA
- Novant Health Heart and Vascular Institute
- Duke University Medical Center (DUMC)
- Raleigh Cardiology Associates
- Novant Health Forsyth Medical Center
- Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital
- Akron General Medical Center
- Northeast Ohio Cardiovascular Specialists
- The Lindner Research Center
- Cleveland Clinic
- University Hospitals Case Medical Center
- OhioHealth Riverside Methodist Hospital
- The Ohio State University
- Saint Elizabeth Health Center
- Mount Carmel East
- Oklahoma Heart Hospital Research Foundation
- University of Oklahoma Health Science Center (OUHSC)
- Oklahoma Heart Institute
- Legacy Medical Group
- Oregon Health & Science University Hospital
- Providence Health & Services
- Lehigh Valley Hospital Cedar Crest
- Saint Luke's Hospital
- Geisinger Medical Center
- Doylestown Cardiology Associates - VIAA
- University of Pittsburgh Medical Center UPMC Hamot
- Saint Mary Medical Center (Langhorne PA)
- Drexel University College of Medicine
- Pennsylvania Hospital
- Temple University Hospital
- Thomas Jefferson University Hospital
- University of Pennsylvania
- Allegheny General Hospital
- University of Pittsburgh Medical Center UPMC Presbyterian
- The Miriam Hospital
- The Stern Cardiovascular Foundation
- Jackson Clinic
- Wellmont CVA Heart Institute
- Centennial Heart Cardiovascular Consultants LLC
- Saint Thomas Research Institute
- Amarillo Heart Group
- Cardiology Associates of Corpus Christi
- Baylor Heart & Vascular Hospital
- North Texas Heart Center
- Plaza Medical Center of Fort Worth
- Longview Regional Medical Center
- Baylor Research Institute
- Scott & White Health Science Ctr
- EP Heart LLC
- The University of Vermont Medical Center Inc
- Virginia Commonwealth University Health System
- Saint Mary's Medical Center
- Aurora BayCare Medical Center
- Bellin Memorial Hospital, Inc.
- Universitätsklinikum Krems
- Universitair Ziekenhuis Brussel
- Ziekenhuis Oost Limburg - Campus St.-Jan
- Centre Hospitalier Regional de la Citadelle
- Saint Paul's Hospital (Vancouver BC)
- Hamilton General Hospital / Hamilton Health Sciences
- University of Ottawa Heart Institute
- Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
- Hospital San Juan de Dios
- Grantham Hospital
- Princess Margaret Hospital
- Rigshospitalet
- Helsinki University Hospital
- Turun Yliopistollinen keskussairaala
- Centre Hospitalier Régional Universitaire de Lille
- Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
- Nouvelles Cliniques Nantaises
- CHU Hôpiteaux de Rouen - Hôpital Charles Nicolle
- Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
- Universitäts-Herz-Zentrum Freiburg - Bad Krozingen
- Universitätsmedizin Rostock
- University General Hospital of Heraklion
- University Hospital of Ioannina
- Onassis Cardiac Surgery Center
- Rabin Medical Center - Beilinson Hospital
- Chaim Sheba Medical Center
- Policlinico Sant' Orsola - Malpighi
- Azienda Ospedaliera Spedali Civili di Brescia
- Presidio Ospedaliero Sant'Anna
- Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
- Hospital Sultanah Bahiyah
- Institut Jantung Negara - National Heart Institute
- Universiti Malaya Medical Centre
- Catharina Ziekenhuis
- St. Antonius Ziekenhuis
- Helse Bergen HF - Haukeland Universitetssjukehus
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
- Szpital Kliniczny Przemienienia Panskiego
- Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
- Centro Hospitalar do Porto
- King Faisal Specialist Hospital & Research Center
- Changi General Hospital
- National Heart Centre Singapore
- Stredoslovensky ustav srdcovych a cievnych chorob a.s
- Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
- Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
- Hospital Marqués de Valdecilla
- Hospital Universitari Bellvitge
- Hospital Universitario La Paz
- Hospital Universitario Ramón y Cajal
- Alingsås Lasarett
- Sahlgrenska Universitetssjukhuset
- Karolinska Universitetssjukhuset
- Sjukhuset i Varberg
- Centre Hospitalier Universitaire Vaudois
- Cardiocentro Ticino
- Kantonsspital St.Gallen
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital
- Central Manchester University Hospitals NHS - Manchester Royal Infirmary
- The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
TYRX™ envelope
Control
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.
No TYRX™ envelope, bare CIED