A Multi-Center Study Evaluating Participants Who Received CanGaroo Envelope, Tyrx Envelope, or No Envelope During CIED Implantation
HEAL Study: Comparison of Participants Who Received a CanGaroo Envelope, Tyrx Envelope, or no Envelope During CIED Implantation
Sponsor: Aziyo Biologics, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAT5350
U.S. Govt. ID: NCT04645173
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: We are doing this study to gather information on participants returning at time of Cardiovascular Implantable Electronic Device (CIED) change-out or revision who underwent a device implantation with either a CanGaroo envelope, Tyrx envelope, or no envelope. A CIED is a device implantable inside the body, able to conduct pacing of the heart and therefore capable of correcting most life-threatening abnormal heart rhythms. People who have had surgery to implant a medical device that helps their heart, may have had their surgery done in slightly different ways. In this study, the investigators are looking for people to participate who need to undergo another surgical procedure to change or revise their implanted heart device. The study will look at several pieces of information that may help provide a better understanding of how your body has healed and also to see if there is any difference between people who had their surgery done in slightly different ways.
Investigator
Hirad Yarmohammadi, MD, MPH
Do You Qualify?
Do you have an Implanted Cardiac Device? Yes No
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You may be eligible for this study

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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366