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."
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."
Study Type
OBSERVATIONAL
Enrollment
1,088
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Number of Participants With Acute Serious Adverse Events
Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Time frame: 0 to 7 days post procedure
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
Late adverse events were defined as those serious events with an onset date \> 7 days post-procedure
Time frame: 7 days through 2 years
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Time frame: Implant through 2 years
Number of Participants With Major Bleeding Events
Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
Time frame: Implant through 2 years
Number of Participants With Technical Success
Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).
Time frame: During implant procedure, approximately 30 to 60 minutes
Number of Participants With Procedural Success
Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event
Time frame: During the implant procedure and hospital stay, approximately 1 or 2 days
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Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Universitaire Ziekenhuizen Gasthuisberg
Leuven, Belgium
Hospital Clinico San Borja Arriaran
Santiago, Chile
Rigshospitalet
Copenhagen, Denmark
Helsinki University Central Hospital
Helsinki, Uusimaa, Finland
Turku University Hospital
Turku, Finland
Hopital Haut Leveque
Pessac, Aquitaine, France
CHU du Bocage
Dijon, Burgundy, France
CHRU Lille
Lille, North-Calais, France
CHU d'Amiens
Amiens, Picardy, France
...and 41 more locations
Number of Participants With Oral Anti-coagulation Usage
Time frame: At discharge, approximately 1 or 2 days after the procedure
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 1 to 3 months
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 6 months
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 12 months
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 24 months