Actively Recruiting
EnCompass Clamp and AtriClip in Box Lesion and Left Atrial Appendage Exclusion Procedure to Prevent New Onset Atrial Fibrillation in Cardiac Surgery
Led by AtriCure, Inc. · Updated on 2026-04-07
960
Participants Needed
16
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Post Operative Atrial Fibrillation (POAF) is a common complication following cardiac surgery, affecting over half of patients depending on their baseline health and type of surgery. Patients who develop POAF often face worse short-term and long-term health outcomes. This trial aims to assess whether adding a preventive procedure involving ablation and exclusion of the Left Atrial Appendage (LAA) during routine cardiac surgery can reduce the occurrence of new atrial fibrillation both shortly after surgery and during long-term follow-up in patients at risk but without prior AF. Participants are randomly assigned to one of two groups: one group receives their planned cardiac surgery plus ablation and LAA exclusion using the Isolator Synergy EnCompass Ablation System and the AtriClip LAA Exclusion System, while the other group undergoes the planned cardiac surgery alone without these additional interventions. The study uses a triple-blind design to monitor results and includes a safety and effectiveness evaluation 30 days after surgery, as well as a longer-term effectiveness assessment over three years. During the trial, participants will be closely monitored for the development of atrial fibrillation and any safety concerns within the first 30 days following surgery. Follow-up assessments continue for up to three years to evaluate the sustained effects of the intervention. The trial includes comprehensive evaluations of heart function, surgical outcomes, and patient health status, with careful tracking of any complications or adverse events related to the procedures.
CONDITIONS
Brief Title
BoxX-NoAF Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned and clinically indicated for cardiac surgery requiring heart-lung bypass and opening of the pericardium
- Age 65 years or older
- CHA2DS2-VASc score of 3 or higher
You will not qualify if you...
- History of atrial fibrillation or atrial flutter before surgery
- Previous surgery involving opening the pericardium or pericardial space
- Undergoing off-pump (without heart-lung machine) surgery
- Prior Left Atrial Appendage occlusion, exclusion, or removal
- Having a permanent pacemaker
- Infiltrative heart diseases such as amyloidosis
- Planned cardiac surgery not using a sternotomy approach
- Planned heart transplant or long-term ventricular assist device implantation
- Presence of ventricular arrhythmia
- Active infection of heart lining (endocarditis)
- Severe heart failure symptoms classified as NYHA Class IV
- Pre-surgery need for intra-aortic balloon pump or intravenous inotropes
- Active systemic infection requiring antibiotics at surgery time
- Known allergy to Nitinol or nickel
- Life expectancy less than one year
- Other medical conditions making participation unsafe or incomplete
- Current participation in another investigational trial or device study
- Mental or psychiatric conditions preventing understanding of the trial
- Pregnancy
- Severe symptomatic carotid artery disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days post index cardiac surgical procedure
Participants undergo planned cardiac surgery with or without the device intervention as assigned, followed by immediate post-operative care.
Approximately 1 to 2 visits around surgery
Duration - Up to 3 years post index cardiac surgical procedure
Participants have follow-up visits to monitor effectiveness and safety outcomes after surgery.
Periodic visits over 3 years
Trial Site Locations
Total: 16 locations
1
St. Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
Morton Plant Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States, 33759
Actively Recruiting
3
St. Joseph's Hospital - BayCare Health System, Inc.
Clearwater, Florida, United States, 33759
Actively Recruiting
4
Orlando Health, Inc.
Orlando, Florida, United States, 32806
Actively Recruiting
5
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
6
Wellstar Health System
Marietta, Georgia, United States, 30062
Actively Recruiting
7
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
10
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
11
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
13
Ascension Saint Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
14
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Actively Recruiting
15
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
16
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
Research Team
B
BoxX-NoAF Trial Inbox
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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