NCT04846127

CanGaroo® Registry Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Elutia Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DEVICE	CanGaroo Envelope	Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.

Timeline

• Start date: 2021-05-25
• Primary completion: 2023-04-17
• Completion: 2024-10-17
• First posted: 2021-04-15
• Last updated: 2025-05-15

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study