BoxX-NoAF Clinical Trial

AtriCure

Status

Not yet enrolling

Conditions

Post Operative Atrial Fibrillation

Atrial Fibrillation, Postoperative

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT06989775

CP-2024-02

Details and patient eligibility

About

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.

Enrollment

960 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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