Retrospective Experience Of CIED Implantation
- Conditions
- Coronary Artery DiseaseCardiac DiseaseHeart 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
- Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017
- 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
Name Time Method Number of Participants With Major Infection Post Procedure 12 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
Name Time Method Number of Participants With Pocket Related Issues Prompting an Office Visit 12 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