Preventing atrial fibrillation with surgical ablation and left atrial appendage clipping during heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BoxX-NoAF randomizes patients without prior atrial fibrillation who are undergoing cardiac surgery with cardiopulmonary bypass to receive prophylactic left atrial ablation plus left atrial appendage (LAA) exclusion or to usual surgical care. The intervention uses the Isolator® Synergy™ EnCompass® Ablation System for lesion creation and the AtriClip® device for LAA exclusion at the time of the index operation. Patients are enrolled at several US centers and followed for postoperative AF and longer-term clinical atrial fibrillation outcomes. The trial targets older patients with elevated CHA2DS2-VASc scores who are at higher risk of developing AF but have not previously had AF or undergone pericardial surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Honor Health
  Scottsdale, Arizona, United States Recruiting
• St. Bernards Medical Center
  Jonesboro, Arkansas, United States Recruiting
• Sharp Memorial Hospital
  San Diego, California, United States Recruiting
• Adventist Health St. Helena
  St. Helena, California, United States Recruiting
• Morton Plant Hospital - BayCare Health System, Inc.
  Clearwater, Florida, United States Recruiting
• St. Joseph's Hospital - BayCare Health System, Inc.
  Clearwater, Florida, United States Recruiting

Study contacts

• Study coordinator: BoxX-NoAF Trial Inbox
• Email: BoxXNoAF@atricure.com
• Phone: 1 (513) 755-4100

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.