Status:
COMPLETED
World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
CIED Related Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
7075 Patients enrolled
Trial Details
Trial ID
NCT02277990
Start Date
January 1 2015
End Date
September 1 2018
Last Update
November 5 2019
Active Locations (181)
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1
Alaska Heart Institute
Anchorage, Alaska, United States
2
Tri-City Cardiology Consultants
Mesa, Arizona, United States
3
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
4
Chula Vista Cardiac Center
Chula Vista, California, United States