RECRUITING Not applicable ClinicalTrials.gov

BoxX-NoAF Clinical Trial

Sponsor: AtriCure, Inc. • ClinicalTrials.gov ID: NCT06989775

Registry updated: 2026-10-07

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Description

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.

Interventions

Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System (Device)
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

Eligibility criteria

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 cardiac surgical procedure using non-sternotomy approaches * Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices * Presence of ventricular arrhythmia * Active endocarditis * NYHA Class IV heart failure symptoms * Preoperative need for an intra-aortic ballon pump or intravenous inotropes * Active systemic infection at the time of cardiac surgery requiring antibiotics * Known allergy to Nitinol or nickel sensitivity * Known medical condition with expected survival of less than 1 year * Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits * Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial * Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial. * Pregnancy * Known severe symptomatic carotid disease

Conditions

Post Operative Atrial Fibrillation Atrial Fibrillation, Postoperative

Locations

Honor Health — Scottsdale, Arizona, United States
St. Bernards Medical Center — Jonesboro, Arkansas, United States
Sharp Memorial Hospital — San Diego, California, United States
Adventist Health St. Helena — St. Helena, California, 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
Naples Comprehensive Health — Naples, Florida, United States
Orlando Health, Inc. — Orlando, Florida, United States
Sarasota Memorial Hospital — Sarasota, Florida, United States
Emory University — Atlanta, Georgia, United States
Piedmont Hospital — Atlanta, Georgia, United States
Wellstar Health System — Marietta, Georgia, United States
Northwestern Memorial Hospital — Chicago, Illinois, United States
Norton Healthcare — Louisville, Kentucky, United States
MedStar Health Research Institute — Baltimore, Maryland, United States
University of Michigan — Ann Arbor, Michigan, United States
Corewell Health — Grand Rapids, Michigan, United States
Trinity Health — Ypsilanti, Michigan, United States
Mayo Clinic — Rochester, Minnesota, United States
BJC Healthcare (Washington University) — St Louis, Missouri, United States
Northwell Health — Manhasset, New York, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York, United States
Bethesda North Hospital — Cincinnati, Ohio, United States
Cleveland Clinic Foundation — Cleveland, Ohio, United States
Promedica Toledo Hospital — Toledo, Ohio, United States
Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
Centennial Medical Center — Nashville, Tennessee, United States
Ascension Saint Thomas — Nashville, Tennessee, United States
St David's HealthCare — Austin, Texas, United States
Baylor Research Institute - Baylor Scott and White Research Institute — Dallas, Texas, United States
Methodist San Antonio — San Antonio, Texas, United States
Charleston Area Medical Center — Charleston, West Virginia, United States
Aspirus Hospital — Wausau, Wisconsin, United States
Royal Columbian Hospital — New Westminster, British Columbia, Canada
Hamilton General Hospital — Hamilton, Ontario, Canada
London Health Sciences Centre, University Hospital — London, Ontario, Canada
Montreal Heart Institute — Montreal, Quebec, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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