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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ cied replacement procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cied replacement procedure
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.
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Who is running the clinical trial?
Medtronic Cardiac Rhythm and Heart FailureLead Sponsor
201 Previous Clinical Trials
130,050 Total Patients Enrolled
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