World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Patient is willing to sign and date the study patient informed consent (PIC) form
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Patient is at least 18 years of age and meets age requirements per local law
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
7,075 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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