Trials / Recruiting
RecruitingNCT06989775
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 960 (estimated)
- Sponsor
- AtriCure, Inc. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-10-24
- Primary completion
- 2028-11-01
- Completion
- 2031-11-01
- First posted
- 2025-05-25
- Last updated
- 2026-04-07
Locations
16 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06989775. Inclusion in this directory is not an endorsement.