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Participants with a previous TYRX™ Absorbable Antibacterial Envelope implant for Cardiovascular Disease

N/A
Waitlist Available
Research Sponsored by Medtronic Cardiac Rhythm and Heart Failure
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cied replacement procedure
Awards & highlights

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.

Eligible Conditions
  • Surgical Wound Healing
  • Cardiovascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cied replacement procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and cied replacement procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Histology of device capsule tissue
Morphology of device capsule tissue

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with a previous TYRX™ Absorbable Antibacterial Envelope implantExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
201 Previous Clinical Trials
130,050 Total Patients Enrolled
~11 spots leftby Sep 2025