MedPath

Retrospective Experience Of CIED Implantation

Completed
Conditions
Coronary Artery Disease
Cardiac Disease
Heart Failure
Registration Number
NCT04351269
Lead Sponsor
Aziyo Biologics, Inc.
Brief Summary

The objective of this study is to retrospectively gather information on patients who underwent a CIED procedure with either a CanGaroo Envelope, TYRX Envelope, or no envelope.

Detailed Description

A single center will retrospectively review up to 700 subjects who underwent implantation of a CIED with a CanGaroo Envelope, TYRX Envelope, or no envelope. All sets of subjects enrolled will also be examined for any follow-up visits and/or adverse events that occurred up to 12 months post-surgery.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
597
Inclusion Criteria
  • Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017
Exclusion Criteria
  • Any patient that had a CIED implanted with any other type of envelope
  • Any patient that had a CIED implanted prior to March 27, 2017

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants With Major Infection Post Procedure12 months post procedure

Major CIED infections are defined as a CIED infection resulting in one or more of the following:

* CIED system removal

* Any invasive procedure (e.g., pocket opened) without system removal

* Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage

* Death

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Pocket Related Issues Prompting an Office Visit12 months post procedure

Any pocket related issues that prompted an office visit

Trial Locations

Locations (1)

Piedmont Athens Electrophysiology

🇺🇸

Athens, Georgia, United States

Piedmont Athens Electrophysiology
🇺🇸Athens, Georgia, United States

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