CanGaroo® Registry Study

Elutia Inc.500 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Arrhythmias, Cardiac

Interventions

CanGaroo EnvelopeDEVICE

Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 3 months post-procedure

Data from ClinicalTrials.gov

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