Micra Atrial TRacking Using A Ventricular AccELerometer 2 (MARVEL 2)
Brief description of study
The purpose of this study is to evaluate the safety and effectiveness of the MARVEL 2 software, which provides synchronous pacing between the upper and lower chambers of the heart. This study will use the Micra pacemaker that subjects already have implanted in their heart. Subjects will not receive a new or different device by participating in this study. The Micra device mentioned above is approved by the FDA for use in subjects who have a heart condition that will be treated by a pacemaker. The ER220 Holter monitor being used for this study is also approved by the FDA to record heart rhythms. The MARVEL 2 software and the antenna for the Holter monitor being used in this study are investigational because they have not been approved by the FDA. However, as part of this study, the study doctor will reprogram your Micra. This will be done with a commercially available Medtronic Carelink Programmer. The MARVEL2 software will be temporarily placed (installed) on the Micra during the Study Procedure visit. It will be removed from the Micra before the end of the visit. Having the MARVEL2 software installed on your Micra pacemaker will change the status of the device from approved for use to investigational for the duration of the study. Investigational means the software has not been approved for commercial use by the US Food and Drug administration (FDA).
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