This will be a prospective, multicenter, observational, non-randomized study to compile real world outcome data on the use of the Amulet™device in non-valvular atrial fibrillation (NVAF) subjects. The study is 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.
Approximately 1000 subjects will be enrolled in the study to reduce the impact of individual center bias, each site may enroll up to 50 subjects. The study will be conducted at up to 75 sites internationally, outside the United States.
The study will be assessing acute and late serious adverse events and report on percentage of stroke and bleeding events through two years.
No formal hypothesis will be tested for this observational post-market study. However, point estimates and exact 95% confidence intervals will be provided for the primary and secondary objectives.
Each patient will be followed for a period of two years after enrollment. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, 1-3 months post implant, 12 months and 24 months.
- Subjects implanted with Amulet Device Device
Intervention Desc: Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device. ARM 1: Kind: Experimental Label: Subjects implanted with Amulet Device Description: All subjects who receive the Amulet device will be followed.
- Perspective: Prospective
- Sampling: Non-Probability Sample
Patients with non-valvular atrial fibrillation
|Type||Measure||Time Frame||Safety Issue|
|Primary||Assessment of acute serious adverse events||0 to 7 days post procedure||No|
|Primary||Assessment of late serious adverse events greater than 7 days post procedure||Greater than 7 days through 2 years||No|
|Primary||Report the composite percentage of stroke (ischemic), systemic embolism and cardiovascular death||implant through 2 years||No|
|Primary||Report the percentage of bleeding events||Implant through 2 years||No|
|Secondary||Technical success||Implant procedure||No|
|Secondary||Procedural success||Implant through hospital discharge||No|
|Secondary||Oral anti-coagulation usage||through 2 years||No|
- St. Jude Medical Lead