MedPath

CanGaroo® Registry Study

Active, not recruiting
Conditions
Arrhythmias, Cardiac
Registration Number
NCT04846127
Lead Sponsor
Aziyo Biologics, Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> 1. Participants for whom this is their first CIED implantation at a particular<br> anatomical site.<br><br> Participants with a history of prior CIED implants at other anatomical sites than<br> the current site can be included, provided that the planned implant location for the<br> current CIED procedure is the first implant procedure at that site.<br><br> 2. Participants aged 18 years or older at time of enrollment.<br><br> 3. Participant is able and agrees to provide written informed consent and use of PHI.<br><br>Exclusion Criteria:<br><br> 1. Participants who have had one or more prior CIED procedures (implantations or<br> revisions) at the current device implant site.<br><br> 2. Participants under the age of 18 at time of enrollment.

Exclusion Criteria

Not provided

Study & Design

Study Type
Observational [Patient Registry]
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Association between participant characteristics and outcomes;Association between CanGaroo envelope use and CIED implant-related outcomes and events.
Secondary Outcome Measures
NameTimeMethod
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