MedTrace Logo

TYRX™ Pocket Health Study

NCT05356546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2023-08-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-07-06
Completion
2023-07-06

Countries

  • United States
  • Canada
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05356546 on ClinicalTrials.gov