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BoxX-NoAF Clinical Trial

RecruitingHealthy volunteers welcome

EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation

Who can join

Ages 65 and older · All sexes · Healthy volunteers welcome

Full eligibility 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

About the study

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.

What is being tested

Sponsor: AtriCure, Inc. · Participants: 960 · Started: Oct 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06989775

Locations in the U.S.

ArkansasSt. Bernards Medical Center, Jonesboro
CaliforniaSharp Memorial Hospital, San Diego
FloridaMorton Plant Hospital - BayCare Health System, Inc., Clearwater
St. Joseph's Hospital - BayCare Health System, Inc., Clearwater
Orlando Health, Inc., Orlando
Sarasota Memorial Hospital, Sarasota
GeorgiaEmory University, Atlanta
Piedmont Hospital, Atlanta
Wellstar Health System, Marietta
IllinoisNorthwestern Memorial Hospital, Chicago
KentuckyNorton Healthcare, Louisville
MarylandMedStar Health Research Institute, Baltimore
MichiganCorewell Health, Grand Rapids
Trinity Health, Ypsilanti
MinnesotaMayo Clinic, Rochester
New YorkNorthwell Health, Manhasset
New York Presbyterian Hospital/Columbia University Irving Medical Center, New York (Not yet recruiting)
OhioBethesda North Hospital, Cincinnati
Cleveland Clinic Foundation, Cleveland
PennsylvaniaAllegheny-Singer Research Institute, Pittsburgh
TennesseeAscension Saint Thomas, Nashville
TexasBaylor Research Institute - Baylor Scott and White Research Institute, Dallas
West VirginiaCharleston Area Medical Center, Charleston
WisconsinAspirus Hospital, Wausau

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.