NCT06989775 · AtriCure, Inc.
BoxX-NoAF Clinical Trial
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Known severe symptomatic carotid disease
Where
- Jonesboro, Arkansas
- San Diego, California
- Clearwater, Florida
- Orlando, Florida
- Sarasota, Florida
- Atlanta, Georgia
- Marietta, Georgia
- Chicago, Illinois
- Louisville, Kentucky
- Baltimore, Maryland
- Grand Rapids, Michigan
- Ypsilanti, Michigan
And 10 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations