Preventing atrial fibrillation with surgical ablation and left atrial appendage clipping during heart surgery

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

This trial tests whether adding surgical ablation and clipping of the left atrial appendage during routine open-heart surgery can prevent postoperative and later atrial fibrillation in older patients at higher stroke risk.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 960 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: AtriCure, Inc. (industry)
• Locations: 16 sites (Jonesboro, Arkansas and 15 other locations)
• Trial ID: NCT06989775 on ClinicalTrials.gov

What this trial studies

BoxX-NoAF randomizes patients without prior atrial fibrillation who are undergoing cardiac surgery with cardiopulmonary bypass to receive prophylactic left atrial ablation plus left atrial appendage (LAA) exclusion or to usual surgical care. The intervention uses the Isolator® Synergy™ EnCompass® Ablation System for lesion creation and the AtriClip® device for LAA exclusion at the time of the index operation. Patients are enrolled at several US centers and followed for postoperative AF and longer-term clinical atrial fibrillation outcomes. The trial targets older patients with elevated CHA2DS2-VASc scores who are at higher risk of developing AF but have not previously had AF or undergone pericardial surgery.

Who should consider this trial

Good fit: Ideal candidates are patients aged 65 or older with CHA2DS2-VASc ≥ 3 who are scheduled for cardiac surgery requiring cardiopulmonary bypass and opening of the pericardium and who have no prior history of AF or prior pericardial procedures.

Not a fit: Patients with any prior documented atrial fibrillation or flutter, prior LAA exclusion, off-pump surgery, prior pericardial opening, or other exclusionary conditions (for example infiltrative cardiomyopathy, active infection, NYHA class IV, or ventricular arrhythmia) are not expected to benefit from this prophylactic approach.

Why it matters

Potential benefit: If successful, this approach could reduce the rate of postoperative AF and lower long-term atrial fibrillation-related complications such as stroke and readmission.

How similar studies have performed: Surgical ablation and LAA exclusion have shown benefit for patients with existing AF, but prophylactic ablation and LAA exclusion in patients without prior AF is relatively novel and has limited direct evidence to date.

Eligibility criteria

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

Where this trial is running

Jonesboro, Arkansas and 15 other locations

• St. Bernards Medical Center — Jonesboro, Arkansas, United States (RECRUITING)
• Morton Plant Hospital - BayCare Health System, Inc. — Clearwater, Florida, United States (RECRUITING)
• St. Joseph's Hospital - BayCare Health System, Inc. — Clearwater, Florida, United States (RECRUITING)
• Orlando Health, Inc. — Orlando, Florida, United States (RECRUITING)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (RECRUITING)
• Wellstar Health System — Marietta, Georgia, United States (RECRUITING)
• Corewell Health — Grand Rapids, Michigan, United States (RECRUITING)
• Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
• Northwell Health — Manhasset, New York, United States (RECRUITING)
• New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York, United States (NOT_YET_RECRUITING)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)
• Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States (RECRUITING)
• Ascension Saint Thomas — Nashville, Tennessee, United States (RECRUITING)
• Charleston Area Medical Center — Charleston, West Virginia, United States (RECRUITING)
• Hamilton General Hospital — Hamilton, Ontario, Canada (RECRUITING)
• Montreal Heart Institute — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: BoxX-NoAF Trial Inbox

Conditions: Post Operative Atrial Fibrillation, Atrial Fibrillation, Postoperative, Post operative AF, Clinical AF