Cardiac Disease, Healing Surgical Wounds
Conditions
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.
Interventions
OTHERStudy-required procedures include: tissue collection from device capsule, questionnaire collection, and photo collection
Enrolled participants will have already received the TYRX™ Absorbable Antibacterial Envelope and will be clinically indicated to have a replacement with any market-released, commercially available (in the geographies they are used) CIED and lead(s) with or without the use TYRX™ Absorbable Antibacterial Envelope, as prescribed by and used on-label by their physician.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphology of device capsule tissue | CIED Replacement Procedure | Measurement of capsule wall thickness (measured in millimeters, mm) in tissue sample |
| Histology of device capsule tissue | CIED Replacement Procedure | Histopathologic examination of tissue sample for extent of fibrosis, inflammation, vascularization, calcification, and adhesions, based on ordinal scoring scale |
Countries
Canada, Italy, United Kingdom, United States
Outcome results
None listed