CanGaroo® Registry Study

Elutia Inc.

Status: Completed

Conditions: Arrhythmias, Cardiac

Treatments: Device: CanGaroo Envelope

Study type: Observational

Funder types: Industry

Identifiers

NCT04846127

CPR-2218

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

CanGaroo Envelope

Description:

Participants who receive a CanGaroo envelope during their CIED implant.

Treatment:

Device: CanGaroo Envelope

No Envelope

Description:

Participants who do not receive an envelope of any kind during their CIED implant.