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. 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 join (things the study team will check)

✅ You may be able to join if…

• Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
• Age ≥ 65 years and CHA2DS2-VASc ≥ 3

🚫 You may not be able to join if…

• 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

Where this trial is running

• St. Bernards Medical Center, Jonesboro, Arkansas, United States
• Sharp Memorial Hospital, San Diego, California, United States
• Morton Plant Hospital - BayCare Health System, Inc., Clearwater, Florida, United States
• St. Joseph's Hospital - BayCare Health System, Inc., Clearwater, Florida, United States
• Orlando Health, Inc., Orlando, Florida, United States
• Sarasota Memorial Hospital, Sarasota, Florida, United States
• Emory University, Atlanta, Georgia, United States
• Piedmont Hospital, Atlanta, Georgia, United States
• Wellstar Health System, Marietta, Georgia, United States
• Northwestern Memorial Hospital, Chicago, Illinois, United States
• Norton Healthcare, Louisville, Kentucky, United States
• MedStar Health Research Institute, Baltimore, Maryland, United States

+ 15 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06989775.