| NCT ID | NCT06989775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AtriCure, Inc. |
| Condition | Post Operative Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 960 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 960 participants in total. It began in 2025-10-24 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06989775 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Post Operative Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06989775 currently recruiting?
Yes, NCT06989775 is actively recruiting participants. Contact the research team at BoxXNoAF@atricure.com for enrollment information.
Where is the NCT06989775 trial being conducted?
This trial is being conducted at Jonesboro, United States, San Diego, United States, Clearwater, United States, Clearwater, United States and 11 additional locations.
Who is sponsoring the NCT06989775 clinical trial?
NCT06989775 is sponsored by AtriCure, Inc.. The trial plans to enroll 960 participants.
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