Micra Transcatheter Pacing Device Study
Sponsor: |
Medtronic Cardiac Rhythm Disease Management |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAN9657 |
U.S. Govt. ID: |
NCT02004873 |
Contact: |
Frederick Ehlert: 212-305-9186 / fae4@columbia.edu |
The purpose of this study is to assess the safety and effectiveness of a pacing device, Micra Transcatheter for patients who have been recommended to get a pacemaker because their heart beats irregularly or is too slow at certain times. A pacemaker senses your hearts activity and stimulates your heart if needed. In this study you will get a Medtronic Micra pacemaker.There are many pacemaker systems approved around the world and available to the general publicHowever, the Micra pacemaker being used in this study is investigational in the U.S. because it hasnot been approved by the Food and Drug Administration (FDA) to be safe and effective. When a newpacemaker or pacing lead is developed, it is first tested extensively in the laboratory. If all tests showthat the pacemaker functions as intended, the first implants in people usually take place as part of aresearch study.
This study is closed
Investigator
Frederick Ehlert, MD
Do you have an existing pacemaker or device implant? |
Yes |
No |