aMAZE CAP is an extension to the current aMAZE Trial investigation (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized registry, to allow ongoing treatment of subjects and the collection of additional safety and effectiveness data at existing aMAZE investigational sites.
For consistency, aMAZE CAP primary and secondary safety and efficacy endpoints, eligibility criteria and follow up visit assessments remain unchanged from the current aMAZE Trial investigation (NCT02517397).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures
Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
Measured by 24-hour Holter Monitoring
Time frame: 12 months following Pulmonary Vein Isolation catheter ablation procedure
Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD
Measured by 24-hour Holter Monitoring
Time frame: Following the 90 day blanking period through 12 months post-index pulmonary vein isolation
Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee
Time frame: 12 months following index pulmonary vein isolation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
St. Vincent's HealthCare
Jacksonville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University / Bluhm Cardiovascular Institute
Chicago, Illinois, United States
Loyola University Center for Heart and Vascular Medicine
Maywood, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States
Iowa Heart Center
West Des Moines, Iowa, United States
...and 15 more locations