No phaseRecruiting
BoxX-NoAF Clinical Trial
EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation
- Sponsor
- AtriCure, Inc. (Industry)
- Enrolment
- 960 planned
- Conditions
- Post Operative Atrial Fibrillation; Atrial Fibrillation, Postoperative
- Interventions
- Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
- Ages
- older adults
- Registry
- NCT06989775
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Primary Effectiveness Endpoint
- Primary Safety Endpoint
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered