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BoxX-NoAF Clinical Trial

NCT06989775 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 960

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Post Operative Atrial Fibrillation
  • Atrial Fibrillation, Postoperative

Interventions

DEVICE

Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System

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

Sponsors & Collaborators

  • AtriCure, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-24
Primary Completion
2028-11-30
Completion
2031-11-30
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06989775 on ClinicalTrials.gov