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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.
Official title: EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
960
Start Date
2025-10-24
Completion Date
2031-11
Last Updated
2026-04-07
Healthy Volunteers
Yes
Interventions
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
Locations (16)
St. Bernards Medical Center
Jonesboro, Arkansas, United States
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States
St. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States
Orlando Health, Inc.
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Wellstar Health System
Marietta, Georgia, United States
Corewell Health
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health
Manhasset, New York, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
Hamilton General Hospital
Hamilton, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada