World-wide Randomized Antibiotic Envelope Infection Prevention Trial
- Conditions
- CIED Related Infection
- Interventions
- Device: TYRX™ Absorbable Antibacterial Envelope
- Registration Number
- NCT02277990
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7075
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TYRX™ envelope TYRX™ Absorbable Antibacterial 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.
- Primary Outcome Measures
Name Time Method 12 Month Kaplan-Meier Estimate of Major CIED Infection Rate 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
- Secondary Outcome Measures
Name Time Method Kaplan-Meier Estimate of a Major Infection Throughout Follow-up 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
* Death12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection 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
12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (181)
Cardiology Associates of Corpus Christi
🇺🇸Corpus Christi, Texas, United States
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
MedStar Health Research Institute
🇺🇸Baltimore, Maryland, United States
OhioHealth Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Szpital Kliniczny Przemienienia Panskiego
🇵🇱Poznań, Poland
King Faisal Specialist Hospital & Research Center
🇸🇦Riyadh, Saudi Arabia
Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE
🇵🇹Lisboa, Portugal
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center (DUMC)
🇺🇸Durham, North Carolina, United States
The Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
University of California San Francisco UCSF Medical Center
🇺🇸San Francisco, California, United States
Centennial Heart Cardiovascular Consultants LLC
🇺🇸Nashville, Tennessee, United States
Saint Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Saint Joseph's Hospital Health Center
🇺🇸Liverpool, New York, United States
Lourdes Cardiology Services
🇺🇸Voorhees, New Jersey, United States
Novant Health Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
University General Hospital of Heraklion
🇬🇷Heraklion, Greece
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Universitätsmedizin Rostock
🇩🇪Rostock, Germany
Saint Mary Medical Center (Langhorne PA)
🇺🇸Newtown, Pennsylvania, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸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
The Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
The Miriam Hospital
🇺🇸East Providence, Rhode Island, United States
North Texas Heart Center
🇺🇸Dallas, Texas, United States
Baylor Research Institute
🇺🇸Plano, Texas, United States
Universitätsklinikum Krems
🇦🇹Krems, Austria
Hospital San Juan de Dios
🇨🇱Santiago, Chile
Turun Yliopistollinen keskussairaala
🇫🇮Turku, Finland
Centre Hospitalier Regional de la Citadelle
🇧🇪Liège, Belgium
EP Heart LLC
🇺🇸The Woodlands, Texas, United States
Grantham Hospital
🇨🇳Hong Kong, China
Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
🇫🇷Saint Priest en Jarez, France
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦Quebec, Canada
Helsinki University Hospital
🇫🇮Helsinki, Finland
Princess Margaret Hospital
🇨🇳Hong Kong, China
Centre Hospitalier Régional Universitaire de Lille
🇫🇷Lille, France
Hamilton General Hospital / Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
CHU Hôpiteaux de Rouen - Hôpital Charles Nicolle
🇫🇷Rouen Cedex 1, France
Universitäts-Herz-Zentrum Freiburg - Bad Krozingen
🇩🇪Bad Krozingen, Germany
Onassis Cardiac Surgery Center
🇬🇷Kallithea, Greece
Presidio Ospedaliero Sant'Anna
🇮🇹Como, Italy
Rabin Medical Center - Beilinson Hospital
🇮🇱Petah Tikva, Israel
Universiti Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
University Hospital of Ioannina
🇬🇷Ioannina, Greece
Hospital Universitari Bellvitge
🇪🇸Barcelona, Spain
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Policlinico Sant' Orsola - Malpighi
🇮🇹Bologna, Italy
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Helse Bergen HF - Haukeland Universitetssjukehus
🇳🇴Bergen, Norway
Central Manchester University Hospitals NHS - Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Centro Hospitalar do Porto
🇵🇹Porto, Portugal
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Catharina Ziekenhuis
🇳🇱Eindhoven, Netherlands
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
🇵🇱Lublin, Poland
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
🇸🇰Bratislava 37, Slovakia
Stredoslovensky ustav srdcovych a cievnych chorob a.s
🇸🇰Banska Bystrica, Slovakia
Hospital Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital
🇬🇧London, United Kingdom
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.
🇸🇰Kosice, Slovakia
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Alingsås Lasarett
🇸🇪Goteborg, Sweden
Sahlgrenska Universitetssjukhuset
🇸🇪Goteborg, Sweden
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Oklahoma Heart Hospital Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
University of Oklahoma Health Science Center (OUHSC)
🇺🇸Oklahoma City, Oklahoma, United States
Alaska Heart Institute
🇺🇸Anchorage, Alaska, United States
Tri-City Cardiology Consultants
🇺🇸Mesa, Arizona, United States
Cardiovascular Consultants Heart Center
🇺🇸Fresno, California, United States
Stanford Hospital & Clinics
🇺🇸Stanford, California, United States
UCSD Medical Center
🇺🇸La Jolla, California, United States
Chula Vista Cardiac Center
🇺🇸Chula Vista, California, United States
Florida Electrophysiology Associates
🇺🇸Atlantis, Florida, United States
Saint Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
SCL Physicians Heart Institute of Colorado
🇺🇸Lafayette, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Advanced Cardiovascular Specialists
🇺🇸Shreveport, Louisiana, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Clearwater Cardiovascular & Interventional Consultants
🇺🇸Clearwater, Florida, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Kootenai Heart Clinics Northwest
🇺🇸Coeur d'Alene, Idaho, United States
NorthShore University Health System
🇺🇸Evanston, Illinois, United States
The University Kansas Medical Center Research Institute Inc
🇺🇸Kansas City, Kansas, United States
Maine Medical Center
🇺🇸Scarborough, Maine, United States
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Great Lakes Heart and Vascular Institute PC
🇺🇸Saint Joseph, Michigan, United States
Delmarva Heart Research Foundation Inc
🇺🇸Salisbury, Maryland, United States
Beaumont Hospital - Royal Oak
🇺🇸Royal Oak, Michigan, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
DLP Marquette Physicians Practices Inc
🇺🇸Marquette, Michigan, United States
North Memorial Heart and Vascular Institute
🇺🇸Robbinsdale, Minnesota, United States
Upper Michigan Cardiovascular Associates PC
🇺🇸Marquette, Michigan, United States
NYU
🇺🇸New York, New York, United States
United Heart and Vascular Clinic
🇺🇸Saint Paul, Minnesota, United States
Hattiesburg Clinic/ Forrest General
🇺🇸Hattiesburg, Mississippi, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Raleigh Cardiology Associates
🇺🇸Raleigh, North Carolina, United States
Asheville Cardiology Associate PA
🇺🇸Asheville, North Carolina, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Saint Anthonys Medical Center
🇺🇸Saint Louis, Missouri, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Rigshospitalet
🇩🇰København, Denmark
Sjukhuset i Varberg
🇸🇪Varberg, Sweden
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
Liverpool Heart and Chest Hospital NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Legacy Medical Group
🇺🇸Portland, Oregon, United States
Oregon Health & Science University Hospital
🇺🇸Portland, Oregon, United States
Providence Health & Services
🇺🇸Portland, Oregon, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
Saint Joseph's Medical Center
🇺🇸Stockton, California, United States
Norton Cardiovascular Associates
🇺🇸Louisville, Kentucky, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Novant Health Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Lehigh Valley Hospital Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Arizona Arrhythmia Consultants
🇺🇸Scottsdale, Arizona, United States
Eisenhower Desert Cardiology Center
🇺🇸Rancho Mirage, California, United States
Penrose St. Francis Hospital
🇺🇸Colorado Springs, Colorado, United States
Prairie Education & Research Cooperative (Springfield IL)
🇺🇸Springfield, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Cardiovascular Research Foundation of Louisiana
🇺🇸Baton Rouge, Louisiana, United States
Englewood Hospital & Medical Center
🇺🇸Englewood, New Jersey, United States
Cornell University Medical Center
🇺🇸New York, New York, United States
Mount Sinai Saint Luke's Hospital
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital
🇺🇸Winston-Salem, North Carolina, United States
Northeast Ohio Cardiovascular Specialists
🇺🇸Akron, Ohio, United States
Saint Elizabeth Health Center
🇺🇸Poland, Ohio, United States
Mount Carmel East
🇺🇸Westerville, Ohio, United States
Saint Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
University of Pittsburgh Medical Center UPMC Hamot
🇺🇸Erie, Pennsylvania, United States
Doylestown Cardiology Associates - VIAA
🇺🇸Doylestown, Pennsylvania, United States
Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Wellmont CVA Heart Institute
🇺🇸Kingsport, Tennessee, United States
Amarillo Heart Group
🇺🇸Amarillo, Texas, United States
Plaza Medical Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
Longview Regional Medical Center
🇺🇸Longview, Texas, United States
Scott & White Health Science Ctr
🇺🇸Temple, Texas, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
The University of Vermont Medical Center Inc
🇺🇸Burlington, Vermont, United States
Saint Mary's Medical Center
🇺🇸Huntington, West Virginia, United States
Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille
🇫🇷Marseille, France
Bellin Memorial Hospital, Inc.
🇺🇸Green Bay, Wisconsin, United States
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
🇮🇹Pisa, Italy
Institut Jantung Negara - National Heart Institute
🇲🇾Kuala Lumpur, Malaysia
Hospital Sultanah Bahiyah
🇲🇾Alor Setar, Kedah, Malaysia
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Changi General Hospital
🇸🇬Singapore, Singapore
Kantonsspital St.Gallen
🇨🇭St. Gallen, Switzerland
Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Saint Paul's Hospital (Vancouver BC)
🇨🇦Vancouver, British Columbia, Canada
Ziekenhuis Oost Limburg - Campus St.-Jan
🇧🇪Genk, Belgium
The Cardiac & Vascular Institute
🇺🇸Gainesville, Florida, United States
Virginia Commonwealth University Health System
🇺🇸Richmond, Virginia, United States
University of Florida Health Shands Hospital
🇺🇸Gainesville, Florida, United States
Mid America Heart Institute (MAHI)
🇺🇸Kansas City, Missouri, United States
Lexington Cardiac Research Foundation
🇺🇸Lexington, Kentucky, United States