TYRX™ Pocket Health Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease; Healing Surgical Wounds
• Intervention / Treatment: Other: Study-required procedures include: tissue collection from device capsule, questionnaire collection, and photo collection

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada
    • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
• Italy
  • Bologna, Italy, 40138
    • Policlinico Sant Orsola - Malpighi
• United Kingdom
  • Liverpool, United Kingdom
    • Liverpool Heart and Chest Hospital NHS Foundation Trust
• United States
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • New Jersey
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • New York, New York, United States, 10065
      • New York-Presbyterian Hospital/Weill Cornell Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The Stern Cardiovascular Foundation
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants with a previous TYRX™ Absorbable Antibacterial Envelope implant; Participants who previously underwent a transvenous CIED implantation with the market released TYRX™ Absorbable Antibacterial Envelope, used for approved indications per country/region, and are returning for a CIED replacement procedure at least 12 months from the prior CIED implantation will be evaluated in this study.

Other: Study-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphology of device capsule tissue	Measurement of capsule wall thickness (measured in millimeters, mm) in tissue sample	CIED Replacement Procedure
Histology of device capsule tissue	Histopathologic examination of tissue sample for extent of fibrosis, inflammation, vascularization, calcification, and adhesions, based on ordinal scoring scale	CIED Replacement Procedure

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): July 6, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Wounds and Injuries; Heart Diseases; Surgical Wound
• Other Study ID Numbers: MDT21029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No