Clinical trial NCT06989775: BoxX-NoAF Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Atrial Fibrillation
Atrial Fibrillation, Postoperative
Keywords: Post operative AF
Clinical AF
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 960
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 30 days post index cardiac surgical procedure
measure: Primary Safety Endpoint
timeFrame: 30 days post index cardiac surgical procedure
Secondary outcomes:
measure: Powered Secondary Effectiveness Endpoint
timeFrame: 3 years post index cardiac surgical procedure
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
References: