CanGaroo® Registry Study

Arrhythmias, Cardiac Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

• NCT number: NCT04846127
• Study type: Observational [Patient Registry]
• Source: Aziyo Biologics, Inc.
• Status: Active, not recruiting
• Start date: May 25, 2021
• Completion date: June 30, 2027