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RECRUITING
NCT06989775
NA

BoxX-NoAF Clinical Trial

Sponsor: AtriCure, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

960

Start Date

2025-10-24

Completion Date

2031-11

Last Updated

2026-04-07

Healthy Volunteers

Yes

Interventions

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

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