This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: * Limited Early Stage (Stage 1): up to 250 subjects at up to 65 sites. (COMPLETED, transitioned to Stage 2) * Pivotal Stage/ Phase III (Stage 2): up to 600 subjects at up to 65 sites. (COMPLETED) All subjects from both stages will be included in the primary analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures
Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
University of California San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
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
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University of California San Francisco
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Stanford University
Stanford, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
St. Vincent's HealthCare
Jacksonville, Florida, United States
...and 43 more locations