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World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT)

Primary Purpose

CIED Related Infection

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
TYRX™ Absorbable Antibacterial Envelope
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for CIED Related Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Active Comparator

No Intervention

Arm Label

TYRX™ envelope

Control

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
October 22, 2014
Last Updated
October 23, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02277990
Brief Title
World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Acronym
WRAP-IT
Official Title
Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIED Related Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7075 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TYRX™ envelope
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No TYRX™ envelope, bare CIED
Intervention Type
Device
Intervention Name(s)
TYRX™ Absorbable Antibacterial Envelope
Primary Outcome Measure Information:
Title
12 Month Kaplan-Meier Estimate of Major CIED Infection Rate
Description
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
Time Frame
Implant to 12 months
Secondary Outcome Measure Information:
Title
12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection
Description
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
Time Frame
Implant to 12 months
Title
12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication
Description
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
Time Frame
Implant to 12 months
Title
Kaplan-Meier Estimate of a Major Infection Throughout Follow-up
Description
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
Time Frame
Throughout study follow-up Kaplan-Meier Estimate is at 36 Months

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
34767985
Citation
Poole JE, Swerdlow CD, Tarakji KG, Mittal S, Ellenbogen KA, Greenspon AJ, Kennergren C, Philbert BT, Moore J, Jones RC, Schaller RD, Hansalia R, Simmers T, Mihalcz A, DeBus B, Lexcen DR, Gunderson B, Wilkoff BL. Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics. Heart Rhythm. 2022 Mar;19(3):363-371. doi: 10.1016/j.hrthm.2021.10.032. Epub 2021 Nov 9.
Results Reference
derived
PubMed Identifier
33478712
Citation
Sohail MR, Corey GR, Wilkoff BL, Poole JE, Mittal S, Kennergren C, Greenspon AJ, Cheng A, Lande JD, Lexcen DR, Tarakji KG. Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial. JACC Clin Electrophysiol. 2021 Jan;7(1):50-61. doi: 10.1016/j.jacep.2020.07.021. Epub 2020 Oct 28.
Results Reference
derived
PubMed Identifier
32915063
Citation
Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Krahn AD, Schloss EJ, Gallastegui JL, Pickett RA, Evonich RF, Roark SF, Sorrentino DM, Sholevar DP, Cronin EM, Berman BJ, Riggio DW, Khan HH, Silver MT, Collier J, Eldadah Z, Holbrook R, Lande JD, Lexcen DR, Seshadri S, Tarakji KG. Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008503. doi: 10.1161/CIRCEP.120.008503. Epub 2020 Sep 11.
Results Reference
derived
PubMed Identifier
32281393
Citation
Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Love JC, Augostini R, Faerestrand S, Wiggins SS, Healey JS, Holbrook R, Lande JD, Lexcen DR, Willey S, Tarakji KG; WRAP-IT Investigators. Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e008280. doi: 10.1161/CIRCEP.119.008280. Epub 2020 Apr 12.
Results Reference
derived
PubMed Identifier
32087357
Citation
Mittal S, Wilkoff BL, Kennergren C, Poole JE, Corey R, Bracke FA, Curnis A, Addo K, Martinez-Arraras J, Issa ZF, Redpath C, Moubarak J, Khelae SK, Boersma LVA, Korantzopoulos P, Krueger J, Lande JD, Morss GM, Seshadri S, Tarakji KG. The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up. Heart Rhythm. 2020 Jul;17(7):1115-1122. doi: 10.1016/j.hrthm.2020.02.011. Epub 2020 Feb 19.
Results Reference
derived
PubMed Identifier
30883056
Citation
Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, Gallastegui J, Pickett RA, Evonich R, Philippon F, McComb JM, Roark SF, Sorrentino D, Sholevar D, Cronin E, Berman B, Riggio D, Biffi M, Khan H, Silver MT, Collier J, Eldadah Z, Wright DJ, Lande JD, Lexcen DR, Cheng A, Wilkoff BL; WRAP-IT Investigators. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. 2019 May 16;380(20):1895-1905. doi: 10.1056/NEJMoa1901111. Epub 2019 Mar 17.
Results Reference
derived

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World-wide Randomized Antibiotic Envelope Infection Prevention Trial

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