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NCT06989775NARecruitingAccepts Healthy Volunteers

BoxX-NoAF Clinical Trial

AtriCure, Inc.

Start Date

10/24/2025

Completion Date

12/1/2029

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 Criteria

Age Range: 65 years to No maximum

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

Interventions

DEVICE

Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System

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Conditions

Post Operative Atrial FibrillationAtrial Fibrillation, Postoperative

Locations

St. Bernards Medical Center

Jonesboro, Arkansas 72401

United States

Sharp Memorial Hospital

San Diego, California 92123

United States

Morton Plant Hospital - BayCare Health System, Inc.

Clearwater, Florida 33759

United States

St. Joseph's Hospital - BayCare Health System, Inc.

Clearwater, Florida 33759

United States

Orlando Health, Inc.

Orlando, Florida 32806

United States

Sarasota Memorial Hospital

Sarasota, Florida 34239

United States

Emory University

Atlanta, Georgia 30308

United States

Piedmont Hospital

Atlanta, Georgia 30309

United States

Wellstar Health System

Marietta, Georgia 30062

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Norton Healthcare

Louisville, Kentucky 40205

United States

MedStar Health Research Institute

Baltimore, Maryland 21218

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

Trinity Health

Ypsilanti, Michigan 48197

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Northwell Health

Manhasset, New York 11030

United States

New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York 10032

United States

Bethesda North Hospital

Cincinnati, Ohio 45242

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania 15212

United States

Ascension Saint Thomas

Nashville, Tennessee 37205

United States

Baylor Research Institute - Baylor Scott and White Research Institute

Dallas, Texas 75204

United States

Charleston Area Medical Center

Charleston, West Virginia 25304

United States

Aspirus Hospital

Wausau, Wisconsin 54401

United States

Hamilton General Hospital

Hamilton, Ontario L8L 2X2

Canada

London Health Sciences Centre, University Hospital

London, Ontario N6A 5A5

Canada

Montreal Heart Institute

Montreal, Quebec H1T 1C8

Canada