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NCT04351269 · ClinicalTrials.gov registry record
Retrospective Experience Of CIED Implantation
A clinical trial of Heart Failure and Coronary Artery Disease, sponsored by Elutia.
- Completed
- Registry status
- 597
- Enrollment target
- 1
- Study location
NCT04351269: Completed study of Heart Failure and Coronary Artery Disease, sponsored by Elutia.
NCT04351269 is a study of Heart Failure and Coronary Artery Disease that has completed, run by Elutia. The registered enrollment target is 597 participants, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04351269, a study of Heart Failure and Coronary Artery Disease, has completed, sponsored by Elutia.
- COMPLETED
- Registry status
- 597 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE CanGaroo Envelope
- DEVICE TYRX Envelope
Study Locations (1)
Georgia
- Piedmont Athens Electrophysiology - Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2020-04-22 |
| Est. Completion | 2021-06-30 |
What the finished NCT04351269 record still lists
NCT04351269 is an observational study that tracks outcomes without assigning an intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, below the 2,048-participant average among 397 other Heart Failure trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which CanGaroo Envelope is the first listed.
NCT04351269 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04351269 about?
NCT04351269 is a clinical study titled "Retrospective Experience Of CIED Implantation". 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.
What is the current status of trial NCT04351269?
This trial is currently completed. The enrollment target is 597 participants. The study started on 2020-04-22. Estimated completion is 2021-06-30.
What conditions does trial NCT04351269 study?
This clinical trial studies the following conditions: Heart Failure, Coronary Artery Disease, Cardiac Disease.
What interventions are being tested in trial NCT04351269?
The interventions under investigation include: CanGaroo Envelope (DEVICE), TYRX Envelope (DEVICE).
Who is sponsoring clinical trial NCT04351269?
This trial is sponsored by Elutia, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04351269 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
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Where NCT04351269's enrollment target sits among peer trials
597 95th of 397 higher than 303 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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