BoxX-NoAF Clinical Trial
Recruiting · NCT06989775 · Interventional (participants receive a specific treatment) · Lead sponsor: AtriCure, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
What this trial 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 take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
27 locations listed across 16 US states.
- 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
- Corewell Health - Grand Rapids, Michigan, United States
- Trinity Health - Ypsilanti, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Northwell Health - Manhasset, New York, United States
- New York Presbyterian Hospital/Columbia University Irving Medical Center - New York, New York, United States
- Bethesda North Hospital - Cincinnati, Ohio, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- Allegheny-Singer Research Institute - Pittsburgh, Pennsylvania, United States
- Ascension Saint Thomas - Nashville, Tennessee, United States
- Baylor Research Institute - Baylor Scott and White Research Institute - Dallas, Texas, United States
- Charleston Area Medical Center - Charleston, West Virginia, United States
- Aspirus Hospital - Wausau, Wisconsin, United States
- Hamilton General Hospital - Hamilton, Ontario, Canada
- London Health Sciences Centre, University Hospital - London, Ontario, Canada
- Montreal Heart Institute - Montreal, Quebec, Canada