Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation

Completed

Conditions studied: Cardiac Disease

In brief

The objective of this study is to gather information on participants returning at time of CIED change-out or revision who underwent a device implantation with either a CanGaroo® envelope, TYRX™ envelope, or no envelope.

Key facts

Study ID

NCT04645173

Run by

Elutia Inc.

People needed

46

Starts

2021-02-02

Expected to finish

2023-12-31

Last updated by the study team

2024-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who previously underwent one or more prior CIED implantations utilizing a CanGaroo® envelope, TYRX™ envelope, or no envelope and are returning for a CIED change-out or revision procedure at least 4 months or longer from their prior procedure.
• The following possible scenarios would be eligible for enrollment:
• a. One prior CIED Implant: i. No envelope ii. CanGaroo® envelope iii. TYRX™ envelope b. Multiple prior CIED Implants (envelope type should remain the same for each participant throughout their implant history): i. No envelope → no envelope ii. No envelope → CanGaroo® envelope iii. No envelope → TYRX™ envelope iv. CanGaroo® envelope → CanGaroo® envelope v. TYRX™ envelope → TYRX™ envelope vi. No envelope → CanGaroo® envelope → CanGaroo® envelope vii. No envelope → no envelope → CanGaroo® envelope viii. No envelope → TYRX™ envelope → TYRX™ envelope ix. No envelope → no envelope → TYRX™ envelope
• Participants aged 18 years or older at time of enrollment.
• Participant is able and agrees to provide written informed consent and use of PHI.
• Participants for whom prior CIED implant history information can be obtained.

You may not qualify if…

• Active infection involving the CIED implant site (clinical diagnosis of an active infection at the time of change-out/revision procedure).
• Participants under the age of 18 at time of enrollment.
• Participants with a history of multiple prior CIED implants over time using more than one type of envelope will be excluded as well as participants with a history of one type of envelope use, but the current pocket does not have an envelope. Scenarios that would be excluded:
• CanGaroo® envelope → TYRX™ envelope
• TYRX™ envelope → CanGaroo® envelope
• CanGaroo® envelope - no envelope
• TYRX™ envelope → no envelope
• No envelope → CanGaroo® envelope → no envelope
• No envelope → TYRX™ envelope → no envelope
• No envelope → CanGaroo® envelope → TYRX™ envelope
• No envelope → TYRX™ envelope → CanGaroo® envelope
• CanGaroo® envelope → no envelope → TYRX™ envelope
• TYRX™ envelope → no envelope → CanGaroo® envelope
• CanGaroo® envelope → TYRX™ envelope → no envelope
• TYRX™ envelope → CanGaroo® envelope → no envelope
• CanGaroo® envelope → CanGaroo® envelope → no envelope
• TYRX™ envelope → TYRX™ envelope → no envelope
• Participants undergoing a change-out or revision procedure less than 4 months from their prior procedure.

Where it is running

• Valley Heart Rhythm Specialists — Chandler, Arizona, United States
• Bay Pines VA — Bay Pines, Florida, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• Prairie Education & Research Cooperative / St. John's Hospital — Springfield, Illinois, United States
• U of L Health/Jewish Hospital — Louisville, Kentucky, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Atrium Health — Concord, North Carolina, United States
• East Carolina University/Vidant Medical Center — Greenville, North Carolina, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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