Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
CanGaroo Envelope Participants who receive a CanGaroo envelope during their CIED implant.
  • Device: CanGaroo Envelope
    Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.
No Envelope Participants who do not receive an envelope of any kind during their CIED implant.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Dedra Bethel
dehicks@utmb.edu

More Details

Status
Recruiting
Sponsor
Aziyo Biologics, Inc.

Study Contact

Stephanie Richardson
678-492-4712
srichardson@aziyo.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.