World-wide Randomized Antibiotic Envelope Infection Prevention Trial

CIED Related Infection Clinical Trial

— WRAP-IT  

Official title:

Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277990
• Other study ID #: WRAP-IT
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: September 2018

Study information

• Verified date: October 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7075
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CIED Related Infection
• Communicable Diseases
• Infection

Intervention

Device:
• TYRX™ Absorbable Antibacterial Envelope

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure	The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Chile,  China,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Malaysia,  Netherlands,  Norway,  Poland,  Portugal,  Saudi Arabia,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 Month Kaplan-Meier Estimate of Major CIED Infection Rate	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	Implant to 12 months
Secondary	12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection	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	Implant to 12 months
Secondary	12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication	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	Implant to 12 months
Secondary	Kaplan-Meier Estimate of a Major Infection Throughout Follow-up	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	Throughout study follow-up Kaplan-Meier Estimate is at 36 Months