NCT02004873

Micra Transcatheter Pacing Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 744 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Interventions

Type	Name	Description
DEVICE	Micra Pacemaker Implant

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-05-01
• Completion: 2017-05-01
• First posted: 2013-12-09
• Last updated: 2018-01-17
• Results posted: 2017-01-05

Locations

56 sites across 19 countries: United States, Australia, Austria, Canada, China, Czechia, Denmark, France, Greece, Hungary, India, Italy, Japan, Malaysia, Netherlands, Serbia, South Africa, Spain, United Kingdom