World-wide Randomized Antibiotic Envelope Infection Prevention Trial

Completed · Phase 4

Conditions studied: CIED Related Infection

In brief

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.

Key facts

Study ID

NCT02277990

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

7075

Starts

2015-01-01

Expected to finish

2018-09-01

Last updated by the study team

2019-11-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Tri-City Cardiology Consultants — Mesa, Arizona, United States
• Arizona Arrhythmia Consultants — Scottsdale, Arizona, United States
• Chula Vista Cardiac Center — Chula Vista, California, United States
• Cardiovascular Consultants Heart Center — Fresno, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Eisenhower Desert Cardiology Center — Rancho Mirage, California, United States
• University of California San Francisco UCSF Medical Center — San Francisco, California, United States
• Stanford Hospital & Clinics — Stanford, California, United States
• Saint Joseph's Medical Center — Stockton, California, United States
• Penrose St. Francis Hospital — Colorado Springs, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• SCL Physicians Heart Institute of Colorado — Lafayette, Colorado, United States
• Danbury Hospital — Danbury, Connecticut, United States
• Hartford Hospital — Hartford, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Florida Electrophysiology Associates — Atlantis, Florida, United States
• Clearwater Cardiovascular & Interventional Consultants — Clearwater, Florida, United States
• The Cardiac & Vascular Institute — Gainesville, Florida, United States
• University of Florida Health Shands Hospital — Gainesville, Florida, United States
• Kootenai Heart Clinics Northwest — Coeur d'Alene, Idaho, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Prairie Education & Research Cooperative (Springfield IL) — Springfield, Illinois, United States
• Saint Vincent Medical Group — Indianapolis, Indiana, United States
• Alaska Heart Institute — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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