TYRX™ Pocket Health Study

Completed

Conditions studied: Cardiac Disease, Healing Surgical Wounds

In brief

Medtronic, Inc. is sponsoring the TYRX™ Pocket Health Study to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.

Key facts

Study ID

NCT05356546

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

36

Starts

2022-05-31

Expected to finish

2023-07-06

Last updated by the study team

2023-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously underwent a transvenous CIED implantation utilizing TYRX™ Absorbable Antibacterial Envelope and is returning for a CIED replacement procedure without planned addition of new or revision of existing leads at least 12 months from the prior CIED implant with use of TYRX™ Absorbable Antibacterial envelope (TYRX procedure of interest)
• a. Participants with history of one or two prior CIED implantation(s) at current implant site can be included, provided there was no invasive intervention to the pocket since the TYRX procedure of interest, defined by Exclusion Criteria #2
• Age is ≥ 18 years (or meets age requirements per local law) at time of enrollment
• Procedure information from participant's TYRX procedure of interest can be obtained
• Date of the TYRX procedure of interest
• Received a TYRX™ Absorbable Antibacterial Envelope during TYRX procedure of interest
• Provides signed and dated authorization and/or consent per institution and local requirements
• Willing and able to comply with the protocol

You may not qualify if…

• Active infection involving the CIED implant site (physical, clinical, or laboratory signs/symptoms consistent with an active infection at time of replacement procedure, including but not limited to pneumonia, urinary tract, cellulitis, endocarditis, or bacteremia)
• Prior history of requiring invasive intervention to the pocket since the TYRX procedure of interest, including but not limited to lead revisions or CIED infection
• Prior history of skin infection at CIED implant site since the TYRX procedure of interest
• Returning for a CIED extraction, system upgrade, CIED replacement with planned lead addition and/or revision, planned lead revision, or pocket revision (e.g., pocket revision due to pain)
• Currently has or requires a submuscular or right-sided CIED implantation, or a subcutaneous implantable cardioverter defibrillator (S-ICD)
• Existing Ventricular Assist Device (VAD)
• Currently receiving hemodialysis or peritoneal dialysis therapy
• Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone (or equivalent)
• Has medical condition or history that precludes participant from participation in the opinion of the Investigator (e.g., too superficial positioning of the CIED)
• Pregnant or breastfeeding participant or participant of childbearing potential and who is not on reliable form of birth regulation method or abstinence
• Legally incompetent or otherwise vulnerable
• Participation in another study that may potentially confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic

Where it is running

• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• New York-Presbyterian Hospital/Weill Cornell Medical Center — New York, New York, United States
• The Stern Cardiovascular Foundation — Germantown, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) — Québec, Canada
• Policlinico Sant Orsola - Malpighi — Bologna, Italy
• Liverpool Heart and Chest Hospital NHS Foundation Trust — Liverpool, United Kingdom

Full record on ClinicalTrials.gov

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