NCT02447081

Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Amplatzer™Amulet™ Observational Post-Market Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,088 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

Detailed description

A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States. The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study. Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."

Conditions

• Atrial Fibrillation
• Thromboembolism
• Stroke

Interventions

Type	Name	Description
DEVICE	Subjects implanted with Amulet Device	Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-10-23
• Completion: 2018-10-23
• First posted: 2015-05-18
• Last updated: 2019-12-30
• Results posted: 2019-12-30

Locations

51 sites across 16 countries: Australia, Belgium, Chile, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom