CanGaroo® Registry Study
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation
1 other identifier
observational
500
1 country
23
Brief Summary
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Typical duration for all trials
23 active sites
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 12, 2021
CompletedFirst Posted
Study publicly available on registry
April 15, 2021
CompletedStudy Start
First participant enrolled
May 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2024
CompletedMay 15, 2025
May 1, 2025
1.9 years
April 12, 2021
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
CanGaroo Envelope
Participants who receive a CanGaroo envelope during their CIED implant.
No Envelope
Participants who do not receive an envelope of any kind during their CIED implant.
Interventions
Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.
Eligibility Criteria
Up to 500 participants who will either receive a CanGaroo envelope or no envelope during their de novo cardiac implantable electronic device implantation.
You may qualify if:
- 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.
- Participants aged 18 years or older at time of enrollment.
- Participant is able and agrees to provide written informed consent and use of PHI.
You may not qualify if:
- Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site.
- Participants under the age of 18 at time of enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elutia Inc.lead
Study Sites (23)
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
The Arrhythmia Center of South Florida
Delray Beach, Florida, 33484, United States
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale, Florida, 33308, United States
VA Medical Center
Gainesville, Florida, 32607, United States
Cardiovascular Associates/Osceola Regional Medical Center
Kissimmee, Florida, 34741, United States
Advent Health
Tampa, Florida, 33613, United States
Baptist Health Floyd
New Albany, Indiana, 47150, United States
St. Joseph Hospital
Lexington, Kentucky, 40504, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Brigham & Women's Hospital, Cardiovascular Division
Boston, Massachusetts, 02115, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Ascension Providence Hospital
Southfield, Michigan, 48075, United States
Metro Health/University of Michigan Health
Wyoming, Michigan, 49519, United States
UNC Health/NC Heart & Vascular Research
Raleigh, North Carolina, 27607, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Mercy Health
Toledo, Ohio, 43608, United States
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74127, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Carolina Heart Specialists
Lancaster, South Carolina, 29720, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Houston Methodist
Houston, Texas, 77030, United States
Heart Rhythm Associates
The Woodlands, Texas, 77380, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas F. Deering, MD
Piedmont Heart Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
April 15, 2021
Study Start
May 25, 2021
Primary Completion
April 17, 2023
Study Completion
October 17, 2024
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share