BoxX-NoAF Clinical Trial

Last updated: June 26, 2026
Sponsor: AtriCure, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Chest Pain

Dysrhythmia

Treatment

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

Clinical Study ID

NCT06989775
CP-2024-02
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

Inclusion Criteria:

  • Planned and clinically indicated for cardiac surgical procedure requiring cardiacbypass and opening of the pericardium

  • Age ≥ 65 years and CHA2DS2-VASc ≥ 3

Exclusion

Exclusion Criteria:

  • Documented history of atrial fibrillation or atrial flutter anytime prior to thecardiac 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 anylong-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 unsuitablecandidate to complete the protocol required intervention or visits

  • Current enrollment in an investigation or trial or an investigational devices orinvestigational drug that would interfere with this trial

  • Mental impairment or other psychiatric conditions which may not allow the patient tounderstand the nature, significance, and scope of the trial.

  • Pregnancy

  • Known severe symptomatic carotid disease

Study Design

Total Participants: 960
Treatment Group(s): 1
Primary Treatment: Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
Phase:
Study Start date:
October 24, 2025
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Hamilton General Hospital

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • London Health Sciences Centre, University Hospital

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Active - Recruiting

  • St. Bernards Medical Center

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • Sharp Memorial Hospital

    San Diego, California 92123
    United States

    Active - Recruiting

  • Morton Plant Hospital - BayCare Health System, Inc.

    Clearwater, Florida 33759
    United States

    Active - Recruiting

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

    Clearwater, Florida 33759
    United States

    Active - Recruiting

  • Orlando Health, Inc.

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Morton Plant Hospital - BayCare Health System, Inc.

    Clearwater 4151316, Florida 4155751 33759
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Piedmont Hospital

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Wellstar Health System

    Marietta, Georgia 30062
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Norton Healthcare

    Louisville, Kentucky 40205
    United States

    Active - Recruiting

  • MedStar Health Research Institute

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Trinity Health

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Northwell Health

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • New York Presbyterian Hospital/Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Bethesda North Hospital

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Ascension Saint Thomas

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • Baylor Research Institute - Baylor Scott and White Research Institute

    Dallas, Texas 75204
    United States

    Active - Recruiting

  • Charleston Area Medical Center

    Charleston, West Virginia 25304
    United States

    Active - Recruiting

  • Aspirus Hospital

    Wausau, Wisconsin 54401
    United States

    Active - Recruiting

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