Consent - Research – Pacemaker or Implantable Cardioverter Defibrillator (ICD)
– Living Donor
You are getting a new pacemaker or implantable cardioverter defibrillator (ICD) or you no longer
need your device and you will have your device removed. When your old device is removed, your
pacemaker or ICD may still work and could be donated to a patient in need. There are patients
throughout the world, mostly in poorer countries, that cannot afford pacemakers or ICDs. These
patients do not have access to these same life-saving devices.
The University of Michigan is working with World Medical Relief and with the support of citizens,
physicians, and funeral directors across the United States to help these patients in need.
Project My Heart - Your Heart is collecting pacemakers and ICDs for potential use in a research
study to determine if reusing your device is safe and effective. You may be able to help save a life by
donating your device to our project. There is no cost to you or to your insurance company. There are
no additional risks for donating and you do not have to donate.
If you have any questions about Project My Heart - Your Heart please ask your health care
provider, visit www.myheartyourheart.org, or contact:
Thomas Crawford, M.D. (University of Michigan Frankel Cardiovascular Center)
Email address: thomcraw@med.umich.edu Phone number: (734) 936-6858
I agree to donate my pacemaker or ICD to the University of Michigan for Project My Heart Your Heart. At this time, I understand that the device will only be used for research. My
device will not be delivered to another state or country or implanted into another person
unless The U.S. Food and Drug Administration (FDA) approves a clinical trial for the reuse of
pacemakers and/or ICDs.
I HAVE READ AND UNDERSTAND THE INFORMATION ON THIS FORM BEFORE I SIGNED IT.
_____________________________________________________________________________
Signature of Patient or Legally Authorized Representative (if patient is a minor or unable to sign)
_____________________________________________________________________________
Printed Name of Legally Authorized Representative (if patient is a minor or unable to sign)
Relationship:
Spouse
Parent
Next-of-Kin
Legal Guardian
DPOA for Healthcare
Date: __________________
(mm/dd/yyyy)
Other (specify): _____________
VER: A/14 HIM: 10/14
The content of this form can be altered for reformatting purposes but text should not be edited for content without express
permission from Thomas Crawford, M.D. (University of Michigan Frankel Cardiovascular Center).
Email: thomcraw@med.umich.edu
Phone number: (734) 936-6858
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