Medtronic Product Surveillance Registry Post Approval Network (PAN)
Sponsor: |
Medtronic |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAK3606 |
U.S. Govt. ID: |
NCT01524276 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
The purpose of this registry is to collect information over time about how Medtronic products are working and/or the outcome of the treatment. The registry will be used to support post-market surveillance/monitoring activities and post-approval studies (e.g., to collect safety and performance information). In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines and patient services/solutions. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and to help leading-edge performance assessment via the least burdensome approach.
Investigator
Frederick Ehlert, MD
Are you of 18 years of age or older? |
Yes |
No |
Is your doctor planning to implant a Medtronic cardiac device? |
Yes |
No |
Will you be able to attend a Columbia group doctor for follow-up? |
Yes |
No |