Status:
RECRUITING
BoxX-NoAF Clinical Trial
Lead Sponsor:
AtriCure, Inc.
Conditions:
Post Operative Atrial Fibrillation
Atrial Fibrillation, Postoperative
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
- Age ≥ 65 years and CHA2DS2-VASc ≥ 3
Exclusion
- 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
Key Trial Info
Start Date :
October 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT06989775
Start Date
October 24 2025
End Date
November 1 2031
Last Update
January 7 2026
Active Locations (8)
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1
St. Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
2
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States, 33759
3
St. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States, 33759
4
Orlando Health, Inc.
Orlando, Florida, United States, 32806