Actively Recruiting
BoxX-NoAF Clinical Trial
Led by AtriCure, Inc. · Updated on 2026-04-07
960
Participants Needed
16
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
BoxX-NoAF Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned and medically required cardiac surgery involving cardiac bypass and opening of the pericardium
- Age 65 years or older
- CHA2DS2-VASc score of 3 or higher
You will not qualify if you...
- History of atrial fibrillation or atrial flutter before surgery
- Previous surgery opening the pericardium or pericardial space
- Undergoing off-pump cardiac surgery
- Previous Left Atrial Appendage occlusion or removal
- Having a permanent pacemaker
- Presence of infiltrative cardiomyopathies like amyloidosis
- Planned cardiac surgery using non-sternotomy methods
- Scheduled heart transplant or long-term ventricular assist device implantation
- Presence of ventricular arrhythmia
- Active endocarditis infection
- New York Heart Association Class IV heart failure symptoms
- Need for intra-aortic balloon pump or intravenous inotropes before surgery
- Active systemic infection requiring antibiotics at time of surgery
- Allergy to Nitinol or nickel
- Medical condition with expected survival less than one year
- Other health issues making the patient unsuitable for the study as determined by the investigator
- Current participation in another investigational drug or device trial that may interfere
- Mental or psychiatric conditions preventing understanding of the trial
- Pregnancy
- Known severe symptomatic carotid artery disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
St. Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States, 33759
Actively Recruiting
3
St. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States, 33759
Actively Recruiting
4
Orlando Health, Inc.
Orlando, Florida, United States, 32806
Actively Recruiting
5
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
6
Wellstar Health System
Marietta, Georgia, United States, 30062
Actively Recruiting
7
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
10
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
11
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
13
Ascension Saint Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
14
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
15
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
16
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
Research Team
B
BoxX-NoAF Trial Inbox
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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