Status:
COMPLETED
TYRX™ Pocket Health Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cardiac Disease
Healing Surgical Wounds
Eligibility:
All Genders
18+ years
Brief Summary
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 el...
Detailed Description
The TYRX™ Pocket Health Study is a prospective, multi-center, single arm, post-market non-interventional study. This global study is planned to be conducted in geographies including, but not limited t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 31 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 6 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05356546
Start Date
May 31 2022
End Date
July 6 2023
Last Update
August 24 2023
Active Locations (9)
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1
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
2
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
3
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
4
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065