Status:
COMPLETED
CanGaroo® Registry Study
Lead Sponsor:
Elutia Inc.
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Brief Summary
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04846127
Start Date
May 25 2021
End Date
October 17 2024
Last Update
May 15 2025
Active Locations (23)
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1
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
2
Daytona Heart Group
Daytona Beach, Florida, United States, 32114
3
The Arrhythmia Center of South Florida
Delray Beach, Florida, United States, 33484
4
Florida Heart Rhythm Specialists, PLLC
Fort Lauderdale, Florida, United States, 33308