BoxX-NoAF Clinical Trial
Part of paid clinical trials in Jonesboro, Arkansas.
- Sponsor
- AtriCure, Inc.
- Study ID
- NCT06989775
- Status
- Recruiting
Conditions
- Atrial Fibrillation, Postoperative
- Post Operative Atrial Fibrillation
Eligibility Criteria
- Sex
- ALL
- Age
- 65 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- 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
Study Details
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.
Key Dates
- First listed
- May 25, 2025
- Start date
- Oct 24, 2025
- Status verified
- Jun 2026
- Primary completion
- Feb 28, 2027
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 960 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: TreatmentIndex cardiac surgery + Ablation + Left Atrial Appendage Exclusion with AtriClip
- No Intervention: ControlIndex cardiac surgery only
Primary Outcome Measure
Primary Effectiveness Endpoint [ Time Frame: 30 days post index cardiac surgical procedure ]
Central Contacts
- BoxX-NoAF Trial Inbox1 (513) 755-4100
Locations (24)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | Jay Bhama, MD (PRINCIPAL_INVESTIGATOR) |
| Sharp Memorial Hospital | San Diego | California | 92123 | Donna Small Karl Limmer, MD (PRINCIPAL_INVESTIGATOR) |
| Morton Plant Hospital - BayCare Health System, Inc. | Clearwater | Florida | 33759 | John Ofenloch, MD (PRINCIPAL_INVESTIGATOR) |
| St. Joseph's Hospital - BayCare Health System, Inc. | Clearwater | Florida | 33759 | Andrew Sherman, MD (PRINCIPAL_INVESTIGATOR) |
| Orlando Health, Inc. | Orlando | Florida | 32806 | Anthony Rongione, MD (PRINCIPAL_INVESTIGATOR) |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | Jeffrey E Sell, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University | Atlanta | Georgia | 30308 | Jeffrey Miller, MD (PRINCIPAL_INVESTIGATOR) |
| Piedmont Hospital | Atlanta | Georgia | 30309 | Gigi Davis Vinod Thourani, MD (PRINCIPAL_INVESTIGATOR) Trent Magruder, MD (SUB_INVESTIGATOR) |
| Wellstar Health System | Marietta | Georgia | 30062 | Theresa Luu, MD (PRINCIPAL_INVESTIGATOR) |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | Leonie Mbouguen Christopher Mehta, MD (PRINCIPAL_INVESTIGATOR) |
| Norton Healthcare | Louisville | Kentucky | 40205 | Steven Peterson, MD (PRINCIPAL_INVESTIGATOR) |
| MedStar Health Research Institute | Baltimore | Maryland | 21218 | Brian Bethea, MD (PRINCIPAL_INVESTIGATOR) |
| Corewell Health | Grand Rapids | Michigan | 49503 | Charles Willekes, MD (PRINCIPAL_INVESTIGATOR) |
| Trinity Health | Ypsilanti | Michigan | 48197 | Robert Lyons, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | Tata Lukman Arman Arghami, M.D., M.P.H (PRINCIPAL_INVESTIGATOR) |
| Northwell Health | Manhasset | New York | 11030 | Lily Greenwald Alan Hartman, MD (PRINCIPAL_INVESTIGATOR) |
| New York Presbyterian Hospital/Columbia University Irving Medical Center | New York | New York | 10032 | Hiroo Takayama, MD (PRINCIPAL_INVESTIGATOR) |
| Bethesda North Hospital | Cincinnati | Ohio | 45242 | Adeteju Mowo-Wale Louis Albert Brunsting, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Laurie Ann Moennich Edward Soltesz, MD (PRINCIPAL_INVESTIGATOR) |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | Stephen Bailey, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension Saint Thomas | Nashville | Tennessee | 37205 | Amber Edwards, MD (PRINCIPAL_INVESTIGATOR) |
| Baylor Research Institute - Baylor Scott and White Research Institute | Dallas | Texas | 75204 | Kelley Hutcheson, MD (PRINCIPAL_INVESTIGATOR) |
| Charleston Area Medical Center | Charleston | West Virginia | 25304 | Hazaim Alwair, MD (PRINCIPAL_INVESTIGATOR) |
| Aspirus Hospital | Wausau | Wisconsin | 54401 | John Johnkoski, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Jonesboro, AR
By research site
Related Studies
- Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery SubjectsPHASE1/PHASE2 · Recruiting · Helios Cardio Inc. · Louisville, Kentucky
- Colchicine's Effect on Inflammatory MarkersPHASE4 · Recruiting · Ayesha Ather · Lexington, Kentucky