Recruiting

BoxX-NoAFBoxX-NoAF Clinical Trial

Sponsor:

AtriCure, Inc.

Code:

NCT06989775

Conditions

Post Operative Atrial Fibrillation

Atrial Fibrillation, Postoperative

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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.

Conditions

Post Operative Atrial Fibrillation

Atrial Fibrillation, Postoperative

Study ID

NCT06989775

Start date

Oct 24, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

960 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment

Index cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip

no intervention: Control

Index cardiac surgery only

Interventions

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

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

Primary outcome measure

Primary Effectiveness Endpoint [ Time Frame: 30 days post index cardiac surgical procedure ]
Primary Safety Endpoint [ Time Frame: 30 days post index cardiac surgical procedure ]

Central Contacts and Locations

Central contacts

BoxX-NoAF Trial Inbox

1 (513) 755-4100 BoxXNoAF@atricure.com

Locations

St. Bernards Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Cary Ball

870-207-3812 cary@cargresearch.com

Principal Investigator:

Jay Bhama, MD

Sharp Memorial Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Kaitlynn Lewis

858-244-6886 klewis@sdcardiac.com

Donna Small

DSmall@sdcardiac.com

Principal Investigator:

Karl Limmer, MD

Morton Plant Hospital - BayCare Health System, Inc.

Recruiting

Clearwater, Florida, United States, 33759

Contacts

Arielle Campos

813-533-1418 arielle.campos@baycare.org

Principal Investigator:

John Ofenloch, MD

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

Recruiting

Clearwater, Florida, United States, 33759

Contacts

Arielle Campos

813-533-1418 arielle.campos@baycare.org

Principal Investigator:

Andrew Sherman, MD

Orlando Health, Inc.

Recruiting

Orlando, Florida, United States, 32806

Contacts

George Ngo

321-843-9657 george.ngo@orlandohealth.com

Principal Investigator:

Anthony Rongione, MD

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Marisa Mamazza

941-262-5802 Marisa-mamazza@smh.com

Tina Ryan

941-262-5801 Tina-ryan@smh.com

Principal Investigator:

Jeffrey E Sell, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Jayne Thompson

404-285-1895 sjdanle@emory.edu

Principal Investigator:

Jeffrey Miller, MD

Piedmont Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Brittney Truss

404-695-7023 Brittney.Truss@piedmont.org

Gigi Davis

Gigi.Davis@piedmont.org

Principal Investigator:

Vinod Thourani, MD

Wellstar Health System

Recruiting

Marietta, Georgia, United States, 30062

Contacts

Autumn Lee

470-793-4040 autumn.lee@wellstar.org

Principal Investigator:

Theresa Luu, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Meredith Chappell

312-926-7312 Meredith.Chappell@nm.org

Leonie Mbouguen

Leonieluciano.mbouguen@nm.org

Principal Investigator:

Christopher Mehta, MD

Norton Healthcare

Recruiting

Louisville, Kentucky, United States, 40205

Contacts

Gretchen Holz

502-629-2858 gretchen.holz@nortonhealthcare.org

System Research

502-629-2858 Systemresearch@nortonhealthcare.org

Principal Investigator:

Steven Peterson, MD

MedStar Health Research Institute

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Keith Moyer

410-554-6550 keith.t.moyer@medstar.net

Principal Investigator:

Brian Bethea, MD

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Denise Wittenbach, BSN RN, CCRC

616-391-2066 denise.wittenbach@corewellhealth.org

Principal Investigator:

Charles Willekes, MD

Trinity Health

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Megan Thompson

734-712-5451 megan_thompson@michiganheart.com

Principal Investigator:

Robert Lyons, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Levi Disrud

507-422-5241 disrud.levi@mayo.edu

Tata Lukman

tata.lukman@mayo.edu

Principal Investigator:

Arman Arghami, M.D., M.P.H

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Sarah Alfaro

516-562-2123 salfaro1@northwell.edu

Lily Greenwald

lgreenwald@northwell.edu

Principal Investigator:

Alan Hartman, MD

Bethesda North Hospital

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Tia Little

513-865-5218 tia_little@trihealth.com

Adeteju Mowo-Wale

adeteju_mowo-wale@trihealth.com

Principal Investigator:

Louis Albert Brunsting, MD

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Anna Marie Simmons

216-444-0379 simmona8@ccf.org

Laurie Ann Moennich

moennil@ccf.org

Principal Investigator:

Edward Soltesz, MD

Allegheny-Singer Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Tracy Spirk

412-359-4025 tracy.spirk@ahn.org

Principal Investigator:

Stephen Bailey, MD

Ascension Saint Thomas

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Cassie Hodges

615-222-3815 cassie.hodges@ascension.org

Principal Investigator:

Amber Edwards, MD

Baylor Research Institute - Baylor Scott and White Research Institute

Recruiting

Dallas, Texas, United States, 75204

Contacts

Jennifer Wei

469-814-4878 Jennifer.Wei@BSWHealth.org

Principal Investigator:

Kelley Hutcheson, MD

Charleston Area Medical Center

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Jordan Campanelli

304-388-9889 Jordan.Campanelli@vandaliahealth.org

Kaylea Hoffman

304-388-9889 Kaylea.Hoffman@vandaliahealth.org

Principal Investigator:

Hazaim Alwair, MD

Aspirus Hospital

Recruiting

Wausau, Wisconsin, United States, 54401

Contacts

Debra Waters

715-847-2273 Debra.Waters@aspirus.org

Principal Investigator:

John Johnkoski, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Courtney Mullen

905-521-2100 courtney.mullen@phri.ca

Sara Eskandarian

Sara.Eskandarian@phri.ca

Principal Investigator:

Richard Whitlock, MD

London Health Sciences Centre, University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Stephanie Fox

519-685-8500 stephanie.fox@lhsc.on.ca

Principal Investigator:

Michael Chu, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Ester Cisneros-Aquilera

514-376-3330 Ester.Cisneros-Aguilera@icm-mhi.org

Alexandre Bergeron

alexandre.bergeron.icm@icm-mhi.org

Principal Investigator:

Denis Bouchard, MD

More Information

Sponsor

AtriCure, Inc.

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

Post operative AF
Clinical AF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AtriCure, Inc. on 2026-06-29.