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
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: t
View:

• Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium

• Age ≥ 65 years and CHA2DS2-VASc ≥ 3

Locations
United States
Florida
Morton Plant Hospital - BayCare Health System, Inc.
RECRUITING
Clearwater
St. Joseph's Hospital - BayCare Health System, Inc.
RECRUITING
Clearwater
Orlando Health, Inc.
RECRUITING
Orlando
Michigan
Corewell Health
RECRUITING
Grand Rapids
Other Locations
Canada
Hamilton General Hospital
NOT_YET_RECRUITING
Hamilton
Contact Information
Primary
BoxX-NoAF Trial Inbox
BoxXNoAF@atricure.com
1 (513) 755-4100
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2031-11
Participants
Target number of participants: 960
Treatments
Experimental: Treatment
Index cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip
No_intervention: Control
Index cardiac surgery only
Related Therapeutic Areas
Sponsors
Leads: AtriCure, Inc.

This content was sourced from clinicaltrials.gov