Amplatzer™Amulet™ Post-Market Study "Amulet™PMS"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • 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.

Trial Design

  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients with non-valvular atrial fibrillation

Outcomes

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

Sponsors