Ablation and LAA Exclusion Systems for Atrial Fibrillation
Trial Summary
What is the purpose of this trial?
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
The BoxX-NoAF trial is for patients at risk of developing Atrial Fibrillation (AF) who haven't yet had it but are undergoing routine cardiac surgery. It aims to see if adding two procedures can prevent post-operative AF and reduce long-term AF incidence.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo index cardiac surgery with or without ablation and Left Atrial Appendage Exclusion
Post-operative Monitoring
Participants are monitored for the occurrence of post operative atrial fibrillation and other safety endpoints
Follow-up
Participants are monitored for the occurrence of clinical atrial fibrillation
Treatment Details
Interventions
- Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
Find a Clinic Near You
Who Is Running the Clinical Trial?
AtriCure, Inc.
Lead Sponsor