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BoxX-NoAF Clinical Trial

AtriCure, Inc. · NCT06989775

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 65+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
960
US sites recruiting
31
Study start
October 24, 2025
Record last updated
October 7, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System

Conditions: Post Operative Atrial Fibrillation; Atrial Fibrillation, Postoperative

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Honor Health

    Scottsdale, AZ 85258

    Site contact: Kiki Miguel · 763-236-9237 · mmiguel@honorhealth.com

  • St. Bernards Medical Center

    Jonesboro, AR 72401

    Site contact: Cary Ball · 870-207-3812 · cary@cargresearch.com

  • Sharp Memorial Hospital

    San Diego, CA 92123

    Site contact: Kaitlynn Lewis · 858-244-6886 · klewis@sdcardiac.com

  • Adventist Health St. Helena

    St. Helena, CA 94574

    Site contact: Shalese Canby · 707-967-5959 · CanbySR@ah.org

  • Morton Plant Hospital - BayCare Health System, Inc.

    Clearwater, FL 33759

    Site contact: Arielle Campos · 813-533-1418 · arielle.campos@baycare.org

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

    Clearwater, FL 33759

    Site contact: Arielle Campos · 813-533-1418 · arielle.campos@baycare.org

  • Naples Comprehensive Health

    Naples, FL 34102

    Site contact: Megan Dalziel · 239-624-8113 · megan.dalziel@nchmd.org

  • Orlando Health, Inc.

    Orlando, FL 32806

    Site contact: George Ngo · 321-843-9657 · george.ngo@orlandohealth.com

  • Sarasota Memorial Hospital

    Sarasota, FL 34239

    Site contact: Marisa Mamazza · 941-262-5802 · Marisa-mamazza@smh.com

  • Emory University

    Atlanta, GA 30308

    Site contact: Jayne Thompson · 404-285-1895 · sjdanle@emory.edu

  • Piedmont Hospital

    Atlanta, GA 30309

    Site contact: Brittney Truss · 404-695-7023 · Brittney.Truss@piedmont.org

  • Wellstar Health System

    Marietta, GA 30062

    Site contact: Autumn Lee · 470-793-4040 · autumn.lee@wellstar.org

  • Northwestern Memorial Hospital

    Chicago, IL 60611

    Site contact: Meredith Chappell · 312-926-7312 · Meredith.Chappell@nm.org

  • Norton Healthcare

    Louisville, KY 40205

    Site contact: Gretchen Holz · 502-629-2858 · gretchen.holz@nortonhealthcare.org

  • MedStar Health Research Institute

    Baltimore, MD 21218

    Site contact: Keith Moyer · 410-554-6550 · keith.t.moyer@medstar.net

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Amanda Kasperek · 734-936-9664 · kasperea@med.umich.edu

  • Corewell Health

    Grand Rapids, MI 49503

    Site contact: Denise Wittenbach, BSN RN, CCRC · 616-391-2066 · denise.wittenbach@corewellhealth.org

  • Trinity Health

    Ypsilanti, MI 48197

    Site contact: Megan Thompson · 734-712-5451 · megan_thompson@michiganheart.com

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Levi Disrud · 507-422-5241 · disrud.levi@mayo.edu

  • BJC Healthcare (Washington University)

    St Louis, MO 63110

    Site contact: Brenna Reilly · 314-747-0707 · brennar@wustl.edu

  • Northwell Health

    Manhasset, NY 11030

    Site contact: Sarah Alfaro · 516-562-2123 · salfaro1@northwell.edu

  • Bethesda North Hospital

    Cincinnati, OH 45242

    Site contact: Tia Little · 513-865-5218 · tia_little@trihealth.com

  • Cleveland Clinic Foundation

    Cleveland, OH 44195

    Site contact: Anna Marie Simmons · 216-444-0379 · simmona8@ccf.org

  • Promedica Toledo Hospital

    Toledo, OH 43614

    Site contact: Vanessa Young · 419-291-3757 · Vanessa.Young@ProMedica.org

  • Allegheny-Singer Research Institute

    Pittsburgh, PA 15212

    Site contact: Tracy Spirk · 412-359-4025 · tracy.spirk@ahn.org

  • Centennial Medical Center

    Nashville, TN 37203

    Site contact: Michael Brown · 615-342-6900 · michael.brown@hcahealthcare.com

  • Ascension Saint Thomas

    Nashville, TN 37205

    Site contact: Cassie Hodges · 615-222-3815 · cassie.hodges@ascension.org

  • St David's HealthCare

    Austin, TX 78705

    Site contact: Shir Yelovitch · 512-459-8753 · Shir.Yelovitch@stdavids.com

  • Baylor Research Institute - Baylor Scott and White Research Institute

    Dallas, TX 75204

    Site contact: Jennifer Wei · 469-814-4878 · Jennifer.Wei@BSWHealth.org

  • Charleston Area Medical Center

    Charleston, WV 25304

    Site contact: Jordan Campanelli · 304-388-9889 · Jordan.Campanelli@vandaliahealth.org

  • Aspirus Hospital

    Wausau, WI 54401

    Site contact: Debra Waters · 715-847-2273 · Debra.Waters@aspirus.org

Study contacts (from the official record)

  • BoxX-NoAF Trial Inbox · 1 (513) 755-4100 · BoxXNoAF@atricure.com
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