Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines Clinical Trial
Official title:
Micra Transcatheter Pacing Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
The study is being conducted in 56 sites located around the world, including 30 sites in the
United States (U.S.).
Up to 780 subjects were planned to be enrolled (i.e. consented) to allow up to 720 subjects
to be implanted enabling at least 600 subjects to be followed for at least 12-months
post-implant.
There are two primary objectives in this study (one safety and one efficacy). The primary
safety objective of the study is to evaluate major complications related to the Micra system
or procedure. The primary safety endpoint was pre-specified to be evaluated at 6-months (183
days) post-implant. The primary efficacy objective, Micra pacing capture thresholds, was also
pre-specified to be evaluated six months post-implant. This study also has a separate long
term safety objective that will provide additional long-term safety data following potential
regulatory submissions.
All subjects will be followed until official study closure (official study closure is defined
as when Medtronic and/or FDA requirements have been satisfied per the Clinical
Investigational Plan and/or by a decision by Medtronic or regulatory authority).
Additionally, the Micra Accelerometer Sensor Sub-Study (MASS) is being conducted at 4 centers
already active in the Micra study in Austria, Spain, Hungary and France. Forty (40) subjects
were enrolled in the Sub-Study, and enrollment in the Sub-Study was complete as of March 31,
2016. The purpose of the Sub-Study is to test feasibility for future enhancements in the
Micra device functionalities.
An algorithm was designed to sense the atrial contraction using the Micra accelerometer.
;