Tests a device procedure to prevent new atrial fibrillation after heart surgery
Tests a device procedure during heart surgery in older adults at risk of atrial fibrillation.
Plain-language title generated from the registry record
Registry title: BoxX-NoAF Clinical Trial
Key facts
- Where
- Ann Arbor, Atlanta, Austin, Baltimore, Charleston, Chicago, Cincinnati, Clearwater, Cleveland, Dallas, Grand Rapids, Jonesboro, Louisville, Manhasset, Marietta, Naples, Nashville, New York, Orlando, Pittsburgh, Rochester, San Antonio, San Diego, Sarasota, Scottsdale, St Louis, St. Helena, Toledo, Wausau, and Ypsilanti, United StatesSee the 33 sites
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- Piedmont HospitalAtlanta, United StatesTaking people
- St David's HealthCareAustin, United StatesTaking people
- MedStar Health Research InstituteBaltimore, United StatesTaking people
- Charleston Area Medical CenterCharleston, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- Bethesda North HospitalCincinnati, United StatesTaking people
- Morton Plant Hospital - BayCare Health System, Inc.Clearwater, United StatesTaking people
- St. Joseph's Hospital - BayCare Health System, Inc.Clearwater, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- Baylor Research Institute - Baylor Scott and White Research InstituteDallas, United StatesTaking people
- Corewell HealthGrand Rapids, United StatesTaking people
- St. Bernards Medical CenterJonesboro, United StatesTaking people
- Norton HealthcareLouisville, United StatesTaking people
- Northwell HealthManhasset, United StatesTaking people
- WellStar Health SystemMarietta, United StatesTaking people
- Naples Comprehensive HealthNaples, United StatesTaking people
- Ascension Saint ThomasNashville, United StatesTaking people
- Centennial Medical CenterNashville, United StatesTaking people
- New York Presbyterian Hospital/Columbia University Irving Medical CenterNew York, United StatesNot yet recruiting
- Orlando Health, Inc.Orlando, United StatesTaking people
- Allegheny-Singer Research InstitutePittsburgh, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Methodist San AntonioSan Antonio, United StatesNo longer taking part
- Sharp Memorial HospitalSan Diego, United StatesTaking people
- Sarasota Memorial HospitalSarasota, United StatesTaking people
- Honor HealthScottsdale, United StatesTaking people
- BJC Healthcare (Washington University)St Louis, United StatesTaking people
- Adventist Health St. HelenaSt. Helena, United StatesTaking people
- ProMedica Toledo HospitalToledo, United StatesTaking people
- Aspirus HospitalWausau, United StatesTaking people
- Trinity HealthYpsilanti, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AtriCure, Inc.
- Trial code
- NCT06989775
- Record updated
- 7 October 2026
- Original 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.Read full original descriptionShow less
EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation
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.
Inclusion: Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium; Age ≥ 65 years and CHA2DS2-VASc ≥ 3.
Exclusion: 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); Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial; 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; NYHA Class IV heart failure symptoms; 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; Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial; Known severe symptomatic carotid disease; Presence of a permanent pacemaker; Infiltrative cardiomyopathies (i.e. amyloidosis); Active endocarditis; Preoperative need for an intra-aortic ballon pump or intravenous inotropes; Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits; Pregnancy.