TYRX™ Pocket Health Study

NCT05356546 | Completed

• 1 other identifier: MDT21029
• Study Type: observational
• Target: 36
• Locations: 4 countries
• Sites: 9

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.

Conditions

Cardiac Disease; Healing Surgical Wounds

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Study-required procedures include: tissue collection from device capsule, questionnaire collection, and photo collection OTHER

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.

Participants with a previous TYRX™ Absorbable Antibacterial Envelope implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (9)

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New York-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10065, United States

Location

The Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Canada

Location

Policlinico Sant Orsola - Malpighi

Bologna, 40138, Italy

Location

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples at least 2 to 3 centimeters (cm) in diameter will be sampled from the device capsule surrounding the implanted CIED for morphometric and histopathology analysis. Samples may be stored for as long as they may be beneficial for study-related analyses.

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 2, 2022
• Study Start: May 31, 2022
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

GB (1); CA (1); US (6); IT (1)