BoxX-NoAF Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAtriCure, Inc.
About 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
This trial accepts healthy volunteersQualifiers
Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
Age ≥ 65 years and CHA2DS2-VASc ≥ 3
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System
DeviceBox lesion ablation with the Isolator Synergy EnCompass Clamp System and LAAE using the AtriClip LAA Exclusion System at the time of planned cardiac surgery
Treatment groups
960 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Effectiveness Endpoint
The occurrence of clinically relevant post operative AF (POAF)
Time frame
30 days post index cardiac surgical procedure2
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 procedureSecondary outcomes
1
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 procedureSponsors and contacts
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Source ClinicalTrials.gov