NCT04351269

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

April 22, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 18, 2022

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

April 15, 2020

Results QC Date

March 4, 2022

Last Update Submit

July 19, 2023

Conditions

Cardiac DiseaseHeart FailureCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants With Pocket Related Issues Prompting an Office Visit

    12 months post procedure

Study Arms (3)

CanGaroo Envelope

Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.

Device: CanGaroo Envelope

TYRX Envelope

Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.

Device: TYRX Envelope

No Envelope

Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.

Interventions

CanGaroo EnvelopeDEVICE

CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation

CanGaroo Envelope
TYRX EnvelopeDEVICE

TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation

TYRX Envelope

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Any patient that had a CIED implanted with either a CanGaroo Envelope, a TYRX Envelope, or no envelope on or after March 27, 2017

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piedmont Athens Electrophysiology

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Heart DiseasesHeart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Limitations and Caveats

The limitations of this study are its retrospective, observational nature, non-randomized design, limited duration of follow up, and single-physician design. The lack of randomization may introduce bias in the selection of patients for implantation with CIED envelopes and in the choice between CanGaroo and TYRX Envelopes. Finally, the duration of follow up may not have captured late adverse events, limiting data on longer-term outcomes.

Results Point of Contact

Title
Associate Director of Clinical Operations
Organization
Aziyo Biologics, Inc.
clinical@aziyo.com
470-514-4085

Study Officials

  • Jerome Riebman, MD

    Aziyo Biologicgs, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

April 22, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

July 21, 2023

Results First Posted

May 18, 2022

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)