CanGaroo® Registry Study

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

Detailed Description
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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.

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

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Device: CanGaroo Envelope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Participants aged 18 years or older at time of enrollment. Participant is able and agrees to provide written informed consent and use of PHI. Exclusion Criteria: Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site. Participants under the age of 18 at time of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CanGaroo Envelope<br>Participants who receive a CanGaroo envelope during their CIED implant. | Device: CanGaroo Envelope<br>* Utilization of a CanGaroo envelope with the CIED during the participant's CIED implant procedure.<br>|
| No Envelope<br>Participants who do not receive an envelope of any kind during their CIED implant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months post-procedure |