EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation
AtriCure, Inc.
Summary
Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type. Patients with POAF tend to have worse acute and long-term clinical outcomes. 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.
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium * Age ≥ 65 years and CHA2DS2-VASc ≥ 3 Exclusion Criteria: * Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery * Prior procedure involving opening the pericardium or entering the pericardial space * Patients undergoing off-pump surgery * Prior LAA occlusion, exclusion, or removal (surgical or percutaneous) * Presence of a permanent pacemaker * Infiltrative cardiomyopathies (i.e. amyloidosis) * Planned card…
Interventions
- DeviceIsolator® 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
Locations (16)
- St. Bernards Medical CenterJonesboro, Arkansas
- Morton Plant Hospital - BayCare Health System, Inc.Clearwater, Florida
- St. Joseph's Hospital - BayCare Health System, Inc.Clearwater, Florida
- Orlando Health, Inc.Orlando, Florida
- Sarasota Memorial HospitalSarasota, Florida
- Wellstar Health SystemMarietta, Georgia