CanGaroo® Registry Study

A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation

A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: CanGaroo Envelope

Detailed Description

This prospective, multi-center study will enroll up to 500 participants who are undergoing their initial CIED implant with either a CanGaroo envelope or no envelope.

Once a participant is enrolled in one of the two cohorts, each participant will have their medical history data reviewed and data will be recorded in the CRF including baseline demographics, medications, and diagnoses.

The details of the CIED procedure including any complications/AEs that occur during the procedure will be captured on the appropriate CRF.

Information collected at the follow-up visits will include documentation of post-procedure status, including any complications, adverse events, or revision/reoperation procedures that occur during the follow-up period. This information will also be collected for any unscheduled follow-ups, visits, or care encounters that occur up to 3 months post-procedure. For participants that agree and qualify for optional long-term follow-up, the same information will be collected at additional follow-up points every six months for up to five years.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Daytona Heart Group
    • Delray Beach, Florida, United States, 33484
      • The Arrhythmia Center of South Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Florida Heart Rhythm Specialists, PLLC
    • Gainesville, Florida, United States, 32607
      • VA Medical Center
    • Kissimmee, Florida, United States, 34741
      • Cardiovascular Associates/Osceola Regional Medical Center
    • Tampa, Florida, United States, 33613
      • Advent Health
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Baptist Health Floyd
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • St. Joseph Hospital
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital, Cardiovascular Division
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Southfield, Michigan, United States, 48075
      • Ascension Providence Hospital
    • Wyoming, Michigan, United States, 49519
      • Metro Health/University of Michigan Health
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • UNC Health/NC Heart & Vascular Research
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional Medical Center
  • Ohio
    • Toledo, Ohio, United States, 43608
      • Mercy Health
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University Center for Health Sciences
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Hospital
  • South Carolina
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • The Woodlands, Texas, United States, 77380
      • Heart Rhythm Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 500 participants who will either receive a CanGaroo envelope or no envelope during their de novo cardiac implantable electronic device implantation.

Description

Inclusion Criteria:

1. Participants for whom this is their first CIED implantation at a particular anatomical site.

   Participants with a history of prior CIED implants at other anatomical sites than the current site can be included, provided that the planned implant location for the current CIED procedure is the first implant procedure at that site.

2. Participants aged 18 years or older at time of enrollment.
3. Participant is able and agrees to provide written informed consent and use of PHI.

Exclusion Criteria:

1. Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site.
2. Participants under the age of 18 at time of enrollment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CanGaroo Envelope; Participants who receive a CanGaroo envelope during their CIED implant.	Device: CanGaroo Envelope; Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.
No Envelope; Participants who do not receive an envelope of any kind during their CIED implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between participant characteristics and outcomes	Cohort comparison of clinically significant factors such as physical and demographic characteristics, medical history risk factors related to post-procedure events, and associations with outcomes and events.	3 months post-procedure
Association between CanGaroo envelope use and CIED implant-related outcomes and events.	Cohort comparison of clinically significant events such as infection, wound healing issues, CIED migration, CIED erosion, or a revision/reoperation procedure.	3 months post-procedure

Collaborators and Investigators

• Sponsor: Elutia Inc.
• Investigators: Principal Investigator: Thomas F. Deering, MD, Piedmont Heart Institute

Publications and helpful links

Helpful Links

• Aziyo Biologics, Inc. website

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): October 17, 2024

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CPR-2218

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.: Yes