BoxX-NoAF
EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation (BoxX-NoAF)
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Clinical Trial Information
Trial Contact: Ngo, George M.; Marquart, Vashnie; Cox, Caitlin L; Harms, Gabrielle T; Velez, Vanessa; Rodriguez, Jessica M; Rodriguez, Adriana C; Soto, William
Trial Phone: 3218439657 ; 321-843-1037 ; 321-841-1505 ; 321.841.3686 ; 321.843.5390 ; 3218413270 ; 321.843.1838 ; 321-843-1179
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IRB No: W25.167.07
Protocol Abbrev: BoxX-NoAF
Principal Investigator: Anthony J. Rongione, MD
Phase: Device: Category B
Age Group: Adult
Secondary Protocol No: CP-2024-02
Treatment: Device: Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery
Therapies Involved: Surgery
ClinicalTrials.gov ID: NCT06989775
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Objective
BoxX-NoAF is a randomized trial to evaluate if prophylactic ablation and exclusion of the Left Atrial Appendage at the time of other routine cardiac surgery can reduce the incidence of post operative AF and clinical AF during long term follow up in patients who have not yet developed AF but are at risk.
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Key Eligibility
Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
Age ≥ 65 years and CHA2DS2-VASc ≥ 3
