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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
960
Box lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery
St. Bernards Medical Center
Jonesboro, Arkansas, United States
RECRUITINGSharp Memorial Hospital
San Diego, California, United States
RECRUITINGMorton Plant Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States
RECRUITINGSt. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States
Primary Effectiveness Endpoint
The occurrence of clinically relevant post operative AF (POAF)
Time frame: 30 days post index cardiac surgical procedure
Primary Safety Endpoint
The composite of the following events: * All cause Mortality * Reoperation * Deep sternal wound infection * Permanent stroke * Prolonged ventilation * Renal failure * 30-day readmission * Atypical left atrial flutter * Phrenic nerve palsy * Major Bleeding
Time frame: 30 days post index cardiac surgical procedure
Powered Secondary Effectiveness Endpoint
The time to first occurrence of clinical atrial fibrillation from 30 days after index cardiac surgical procedure through 3-years
Time frame: 3 years post index cardiac surgical procedure
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Orlando Health, Inc.
Orlando, Florida, United States
RECRUITINGSarasota Memorial Hospital
Sarasota, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGPiedmont Hospital
Atlanta, Georgia, United States
RECRUITINGWellstar Health System
Marietta, Georgia, United States
RECRUITINGNorthwestern Memorial Hospital
Chicago, Illinois, United States
RECRUITING...and 17 more locations