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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02277990
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : October 24, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE October 29, 2014
Results First Submitted Date  ICMJE October 2, 2019
Results First Posted Date  ICMJE October 24, 2019
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
12 Month Kaplan-Meier Estimate of Major CIED Infection Rate [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
The first occurrence of a major CIED infection. [ Time Frame: 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 dehiscensce, erosion, or purulent drainage
  • Death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • 12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection [ Time Frame: 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 [ Time Frame: 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
  • Kaplan-Meier Estimate of a Major Infection Throughout Follow-up [ Time Frame: 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
    • Death
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2014)
  • The first occurrence of a major or minor CIED infection [ Time Frame: 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
  • The first occurrence of a CIED procedure related or system related complication [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Official Title  ICMJE Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE CIED Related Infection
Intervention  ICMJE Device: TYRX™ Absorbable Antibacterial Envelope
Study Arms  ICMJE
  • Active Comparator: TYRX™ 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.
    Intervention: Device: TYRX™ Absorbable Antibacterial Envelope
  • No Intervention: Control
    No TYRX™ envelope, bare CIED
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2018)
7075
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2014)
7764
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02277990
Other Study ID Numbers  ICMJE WRAP-IT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE The Cleveland Clinic
Investigators  ICMJE
Study Chair: Bruce Wilkoff, MD The Cleveland Clinic
Principal Investigator: Khaldoun Tarakji, MD The Cleveland Clinic
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP