Retrospective Experience Of CIED Implantation

July 19, 2023 updated by: Aziyo Biologics, Inc.

Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

597

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Athens, Georgia, United States, 30606
        • Piedmont Athens Electrophysiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female patients who underwent a CIED implantation utilizing a CanGaroo Envelope hydrated in saline, a CanGaroo Envelope hydrated in an antibiotic solution, a TYRX Envelope, or no envelope.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CanGaroo Envelope
Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
Device: CanGaroo Envelope
CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
TYRX Envelope
Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
Device: TYRX Envelope
TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation
No Envelope
Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aziyo Biologics, Inc.

Investigators

  • Study Director: Jerome Riebman, MD, Aziyo Biologicgs, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR-2212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on CanGaroo Envelope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe