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OpenTrials
Completed

NCT Number: NCT04351269

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.

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Key information

Conditions

Cardiac Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Failure Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Piedmont Athens Electrophysiology

Athens, Georgia, 30606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CanGaroo Envelope

Device

CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation

TYRX Envelope

Device

TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation

Primary outcomes

  1. Number of Participants With Major Infection Post Procedure

    Time frame: 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 outcomes

  1. Number of Participants With Pocket Related Issues Prompting an Office Visit

    Time frame: 12 months post procedure

    Any pocket related issues that prompted an office visit

Sponsors and collaborators

Lead sponsor

Elutia Inc.

Industry

Registry information

Official study title

Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2020
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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