A Study To Compare The Rate Of Major Cardiovascular Implantable Electronic Device Infections With The Absorbable Antibacterial Envelope And Without
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004798
NCT ID: NCT02277990
Sponsor Protocol Number: WRAP-IT
About this study
The purpose of this study is to evaluate the ability of the TYRX Absorbable Antibacterial Envelope to reduce major cardiovascular implantable electronic device infections through 12-months post-procedure following generator replacement, upgrade, revision, or new CRT-D implant.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Willing to sign and date the study patient informed consent form
- At least 18 years of age and meets age requirements per local law
- Planned to undergo at least one of the following
- Has existing cardiovascular implantable electronic device and is undergoing IPG (including CRT-P), ICD or CRT-D replacement or upgrade with a new Medtronic generator is planned to have leads added, or extracted ,or upgrades can be enrolled
- Will undergo a new Medtronic CRT-D system implant per approved indications
- had 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
- 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
- Coenrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Malini Madhavan, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available