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

NCT04645173 | Completed FDA Device

• 1 other identifier: CPR-2214
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Blinded Histologic Evaluation of Biopsies Taken from the Anterior and Posterior Capsule Wall

  Microscopic analysis of cellularity, vascularity, collagen density, necrosis, infectious agents, remnant device material, giant cells, and fibrotic capsule thickness will be evaluated for each biopsy site using a quantitative scoring system with an attempt to distinguish between remnant envelope collagen (if ECM envelope was used) and neocollagen from the participant. Composite (total) and average scores will be determined based on the individual scores from each biopsy site. The quantitative thickness of each fibrotic capsule biopsy will be measured using digital image software. Four (4) thickness measurements will be performed across the image for each biopsy sample, and the average fibrotic thickness will be reported for each sample. In addition, the total average thickness across the four samples will be determined based on the average individual recordings.

  Surgical Procedure Visit

Secondary Outcomes (1)

• Documented CIED Complications

  Pre-Surgery Visit

Other Outcomes (4)

• Patient and Observer Scar Assessment Scale (POSAS)

  Pre-Surgery Visit

• CIED Scar Photographs

  Pre-Surgery Visit

• CIED Implant Photographs

  Surgical Procedure Visit

Study Arms (3)

CanGaroo Envelope

Participants who received a CanGaroo envelope during CIED implantation

Device: CIED envelope

TYRX Envelope

Participants who received a TYRX envelope during CIED implantation

Device: CIED envelope

No Envelope

Participants who did not receive an envelope during CIED implantation

Interventions

CIED envelope DEVICE

Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.

CanGaroo Envelope; TYRX Envelope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who underwent one or more prior CIED implantation procedure at the current implant site utilizing CanGaroo®, TYRX™, or no envelope and are returning for a CIED change-out or revision procedure.

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

Sponsors & Collaborators

• Elutia Inc.: lead

Study Sites (11)

Valley Heart Rhythm Specialists

Chandler, Arizona, 85224, United States

Location

Bay Pines VA

Bay Pines, Florida, 33744, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Prairie Education & Research Cooperative / St. John's Hospital

Springfield, Illinois, 62769, United States

Location

U of L Health/Jewish Hospital

Louisville, Kentucky, 40241, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Atrium Health

Concord, North Carolina, 28025, United States

Location

East Carolina University/Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

Related Links

• Aziyo Biologics, Inc.

Biospecimen

Retention: SAMPLES WITH DNA

Characteristics of soft tissue healing surrounding the CIED implant as assessed by blinded histologic evaluation of systematic biopsies taken at the time of change-out/revision.

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 27, 2020
• Study Start: February 2, 2021
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)