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


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

1. Subject with history of paroxysmal, persistent or permanent NVAF
2. Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
3. Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
4. Subject who is willing and capable of providing informed consent, participating in all associated study activities

Exclusion Criteria

1. Subject with evidence of an intracardiac thrombus
2. Subject with active infection or active endocarditis or other infections producing bacteremia
3. Subject where the placement of the device would interfere with any intracardiac or intravascular structures
4. Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
6. Subject with LAA anatomy that does not accommodate a device per the sizing guidelines