NCT02488681

Micra Transcatheter Pacing System Continued Access Study Protocol

Medtronic Micra Transcatheter Pacing System Continued Access Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Medtronic is sponsoring the Micra Continued Access (CA) study to provide continued access to the Micra System while the marketing application is under review by the Food and Drug Administration (FDA).

Detailed description

The Micra CA study is a prospective, non-randomized, multi-center, study designed to allow controlled access of the Micra system when used as intended. All subjects enrolled in the Micra CA Study will be prospectively followed from implant, at 6-month intervals until study closure (i.e. FDA approval). Patients with previous or existing inactive implanted cardiac stimulation systems will have additional follow ups.

Conditions

• Bradycardia

Interventions

Type	Name	Description
DEVICE	Micra Pacemaker Implant

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-07-02
• Last updated: 2018-04-12
• Results posted: 2018-01-03

Locations

29 sites across 1 country: United States