N/A
N=597
Retrospective Experience Of CIED Implantation
Cardiac Disease · Heart Failure · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT04351269 ↗Enrolled (actual)
597
Serious AEs
3.7%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With Major Infection Post Procedure — 2; 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CanGaroo Envelope (Device); TYRX Envelope (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Elutia Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Infection Post Procedure |
2; 0; 0 | — |
| SECONDARY Number of Participants With Pocket Related Issues Prompting an Office Visit |
2; 2; 0; 2; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04351269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.