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BoxX-NoAF Clinical Trial

RecruitingNAAges 65 Years - anyAllAtriCure, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

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

37 sites
Honor Health
Scottsdale, United States
St. Bernards Medical Center
Jonesboro, United States
Sharp Memorial Hospital
San Diego, United States
Adventist Health St. Helena
St. Helena, United States
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater, United States
St. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, United States
Naples Comprehensive Health
Naples, United States
Orlando Health, Inc.
Orlando, United States

…and 29 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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