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Clinical Trials in the USA / NCT06989775
Recruiting Not applicable

BoxX-NoAF Clinical Trial

NCT06989775 · tracked via the Priya Life Science USA tracker
Sponsor
AtriCure, Inc.
Phase
Not applicable
Started
2025-10-24
Last updated
2026-06-29

Condition(s) studied

Post Operative Atrial FibrillationAtrial Fibrillation, Postoperative

Investigational drug(s) / intervention(s)

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

Isolator® 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

Study 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

Sex
ALL
Min age
65 Years
Max age
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
St. Bernards Medical Center Jonesboro Arkansas Recruiting
Sharp Memorial Hospital San Diego California Recruiting
Morton Plant Hospital - BayCare Health System, Inc. Clearwater Florida Recruiting
St. Joseph's Hospital - BayCare Health System, Inc. Clearwater Florida Recruiting
Orlando Health, Inc. Orlando Florida Recruiting
Sarasota Memorial Hospital Sarasota Florida Recruiting
Emory University Atlanta Georgia Recruiting
Piedmont Hospital Atlanta Georgia Recruiting
Wellstar Health System Marietta Georgia Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Norton Healthcare Louisville Kentucky Recruiting
MedStar Health Research Institute Baltimore Maryland Recruiting
Corewell Health Grand Rapids Michigan Recruiting
Trinity Health Ypsilanti Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Northwell Health Manhasset New York Recruiting
New York Presbyterian Hospital/Columbia University Irving Medical Center New York New York Not Yet Recruiting
Bethesda North Hospital Cincinnati Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Allegheny-Singer Research Institute Pittsburgh Pennsylvania Recruiting
Ascension Saint Thomas Nashville Tennessee Recruiting
Baylor Research Institute - Baylor Scott and White Research Institute Dallas Texas Recruiting
Charleston Area Medical Center Charleston West Virginia Recruiting
Aspirus Hospital Wausau Wisconsin Recruiting
Hamilton General Hospital Hamilton Ontario Recruiting
London Health Sciences Centre, University Hospital London Ontario Recruiting
Montreal Heart Institute Montreal Quebec Recruiting

More AtriCure, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06989775 on ClinicalTrials.gov ↗ ← All trials in the USA