Retrospective Experience Of CIED Implantation

Coronary Artery Disease Clinical Trial

Official title:

Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351269
• Other study ID #: CPR-2212
• Status: Completed
• Start date: April 22, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2023
• Source: Aziyo Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 597
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Coronary Artery Disease
• Heart Diseases
• Heart Failure

Intervention

Device:
• CanGaroo Envelope
CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
• TYRX Envelope
TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation

Locations

Country	Name	City	State
United States	Piedmont Athens Electrophysiology	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Major Infection 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	Number of Participants With Pocket Related Issues Prompting an Office Visit	Any pocket related issues that prompted an office visit	12 months post procedure