BoxX-NoAF Clinical Trial

June 26, 2026 updated by: AtriCure, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

960

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Centre, University Hospital
        • Contact:
        • Principal Investigator:
          • Michael Chu, MD
    • Quebec
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • St. Bernards Medical Center
        • Principal Investigator:
          • Jay Bhama, MD
        • Contact:
    • California
      • San Diego, California, United States, 92123
        • Recruiting
        • Sharp Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karl Limmer, MD
    • Florida
      • Clearwater, Florida, United States, 33759
        • Recruiting
        • Morton Plant Hospital - BayCare Health System, Inc.
        • Contact:
        • Principal Investigator:
          • John Ofenloch, MD
      • Clearwater, Florida, United States, 33759
        • Recruiting
        • St. Joseph's Hospital - BayCare Health System, Inc.
        • Principal Investigator:
          • Andrew Sherman, MD
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health, Inc.
        • Contact:
        • Principal Investigator:
          • Anthony Rongione, MD
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeffrey E Sell, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Jeffrey Miller, MD
        • Contact:
      • Marietta, Georgia, United States, 30062
        • Recruiting
        • Wellstar Health System
        • Contact:
        • Principal Investigator:
          • Theresa Luu, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Medstar Health Research Institute
        • Contact:
        • Principal Investigator:
          • Brian Bethea, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
        • Principal Investigator:
          • Charles Willekes, MD
        • Contact:
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arman Arghami, M.D., M.P.H
    • New York
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10032
        • Not yet recruiting
        • New York Presbyterian Hospital/Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Hiroo Takayama, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Edward Soltesz, MD
        • Contact:
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny-Singer Research Institute
        • Contact:
        • Principal Investigator:
          • Stephen Bailey, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Ascension Saint Thomas
        • Principal Investigator:
          • Amber Edwards, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75204
        • Recruiting
        • Baylor Research Institute - Baylor Scott and White Research Institute
        • Contact:
        • Principal Investigator:
          • Kelley Hutcheson, MD
    • West Virginia
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Hospital
        • Contact:
        • Principal Investigator:
          • John Johnkoski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Index cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip
Device: 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
No Intervention: Control
Index cardiac surgery only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 30 days post index cardiac surgical procedure
The occurrence of clinically relevant post operative AF (POAF)
30 days post index cardiac surgical procedure
Primary Safety Endpoint
Time Frame: 30 days post index cardiac surgical procedure

The composite of the following events:

  • All cause Mortality
  • Reoperation
  • Deep sternal wound infection
  • Permanent stroke
  • Prolonged ventilation
  • Renal failure
  • 30-day readmission
  • Atypical left atrial flutter
  • Phrenic nerve palsy
  • Major Bleeding
30 days post index cardiac surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Powered Secondary Effectiveness Endpoint
Time Frame: 3 years post index cardiac surgical procedure
The time to first occurrence of clinical atrial fibrillation from 30 days after index cardiac surgical procedure through 3-years
3 years post index cardiac surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 12, 2025

First Submitted That Met QC Criteria

May 23, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-2024-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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