RecruitingNot ApplicableNCT06989775

BoxX-NoAF Clinical Trial

EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation


Sponsor

AtriCure, Inc.

Enrollment

960 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device and procedure designed to prevent new-onset atrial fibrillation (an irregular heartbeat) in patients who are already undergoing open-heart surgery. The device works by closing off the left atrial appendage (a small pouch in the heart where irregular heart rhythms often originate) during the surgery. **You may be eligible if...** - You are 65 or older - You are already scheduled for an open-heart surgical procedure that requires a heart-lung bypass machine - Your stroke risk score (CHA2DS2-VASc) is 3 or higher **You may NOT be eligible if...** - You have a prior history of atrial fibrillation or atrial flutter at any time - You have had a prior open-heart surgery or procedure involving the heart sac (pericardium) - You have a permanent pacemaker - You have certain heart muscle diseases (e.g., amyloidosis) or ventricular arrhythmias - Your surgery is a heart transplant or ventricular assist device implant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIsolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System

Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery


Locations(16)

St. Bernards Medical Center

Jonesboro, Arkansas, 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

Wellstar Health System

Marietta, Georgia, United States

Corewell Health

Grand Rapids, 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

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Allegheny-Singer Research Institute

Pittsburgh, Pennsylvania, United States

Ascension Saint Thomas

Nashville, Tennessee, United States

Charleston Area Medical Center

Charleston, West Virginia, United States

Hamilton General Hospital

Hamilton, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT06989775


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