Atrial fibrillation Atrial fibrillation
Conditions
Interventions
The device is intended to reduce the risk of thromboembolism from the LAA in patients with non-valvular AF who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc sc
Sponsors
Kozuma Ken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder) 2.At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of more than 3 3.Eligible for long-term NOAC therapy 4.Able to comply with the required NOAC medication regimen if randomized to the Control Group 5.Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in
Exclusion criteria
Exclusion criteria: 1.Requires long-term OAC therapy for a condition other than AF 2.Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable) 3.Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use 4.Indicated for P2Y12 platelet inhibitor for > 1 year post-randomization 5.In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure 6.Has undergone atrial septal defect (ASD) repair or has an ASD closure device present 7.Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted 8.Is implanted with a mechanical valve prosthesis 9.Is implanted with an inferior vena cava filter 10.History of rheumatic or congenital mitral valve heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Composite of ischemic stroke, systemic embolism, or CV mortality through 2 years (non-inferiority) 2.Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events through 2 years (superiority) | — |
Countries
Australia, Canada, Czech Republic, Denmark, England, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Switzerland, US
Contacts
Public ContactMizuho Nakagaki
Abbott Medical Japan LLC
Outcome results
None listed