Clinical trial NCT05356546: TYRX™ Pocket Health Study
Official title: TYRX™ Pocket Health Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Healing Surgical Wounds
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2022-05-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with one or more prior transvenous CIED implantation at the current implant site utilizing TYRX™ Absorbable Antibacterial Envelope and are returning for a clinically indicated CIED replacement procedure.

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 electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.

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 to, the United States (US), Canada, and Europe, at approximately 5 to 10 centers and will enroll up to 35 subjects with analyzable tissue samples. All enrolled subjects must have an existing CIED (implantable pulse generator (IPG), cardiac resynchronization therapy pacemaker (CRT-P), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)) that was implanted with the TYRX™ Absorbable Antibacterial Envelope and are returning for a clinically indicated CIED generator replacement without the planned addition of new or revision of existing leads.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Age is ≥ 18 years (or meets age requirements per local law) at time of enrollment
3. Procedure information from participant's TYRX procedure of interest can be obtained

   1. Date of the TYRX procedure of interest
   2. Received a TYRX™ Absorbable Antibacterial Envelope during TYRX procedure of interest
4. Provides signed and dated authorization and/or consent per institution and local requirements
5. Willing and able to comply with the protocol

Exclusion Criteria:

1. 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)
2. 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
3. Prior history of skin infection at CIED implant site since the TYRX procedure of interest
4. 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)
5. Currently has or requires a submuscular or right-sided CIED implantation, or a subcutaneous implantable cardioverter defibrillator (S-ICD)
6. Existing Ventricular Assist Device (VAD)
7. Currently receiving hemodialysis or peritoneal dialysis therapy
8. Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone (or equivalent)
9. Has medical condition or history that precludes participant from participation in the opinion of the Investigator (e.g., too superficial positioning of the CIED)
10. Pregnant or breastfeeding participant or participant of childbearing potential and who is not on reliable form of birth regulation method or abstinence
11. Legally incompetent or otherwise vulnerable
12. 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

Primary outcomes:
measure: Morphology of device capsule tissue
timeFrame: CIED Replacement Procedure
measure: Histology of device capsule tissue
timeFrame: CIED Replacement Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: Germantown
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
city: Bologna
country: Italy
facility: Policlinico Sant Orsola - Malpighi
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
Study officials:
References: