JPRN-jRCT2072220013
Recruiting
Phase 3
Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants - CATALYST
Kozuma Ken0 sites120 target enrollmentJune 9, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kozuma Ken
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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