A Study to Compare the Rate of Major Cardiovascular Implantable Electronic Device Infections with the Absorbable Antibacterial Envelope and without

Overview

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

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

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