BoxX-NoAF Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Isolator® Synergy™ EnCompass® Ablation System and AtriClip® LAA Exclusion System.
- Who it may be relevant to
- Registry conditions: Post Operative Atrial Fibrillation, Atrial Fibrillation, Postoperative. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EnCompass Clamp and the AtriClip in Box Lesion and Left Atrial Appendage EXclusion Procedure for the Prevention of New Onset of Atrial Fibrillation
Overview
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.
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
Primary outcome measures
- Primary Effectiveness Endpoint [Time frame: 30 days post index cardiac surgical procedure]
- Primary Safety Endpoint [Time frame: 30 days post index cardiac surgical procedure]
Secondary outcome measures (1)
- Powered Secondary Effectiveness Endpoint [Time frame: 3 years post index cardiac surgical procedure]
Eligibility criteria
Inclusion criteria
- Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
- Age ≥ 65 years and CHA2DS2-VASc ≥ 3
Exclusion criteria
- Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery
- Prior procedure involving opening the pericardium or entering the pericardial space
- Patients undergoing off-pump surgery
- Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
- Presence of a permanent pacemaker
- Infiltrative cardiomyopathies (i.e. amyloidosis)
- Planned cardiac surgical procedure using non-sternotomy approaches
- Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices
- Presence of ventricular arrhythmia
- Active endocarditis
- NYHA Class IV heart failure symptoms
- Preoperative need for an intra-aortic ballon pump or intravenous inotropes
- Active systemic infection at the time of cardiac surgery requiring antibiotics
- Known allergy to Nitinol or nickel sensitivity
- Known medical condition with expected survival of less than 1 year
- Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits
- Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial
- Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
- Pregnancy
- Known severe symptomatic carotid disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 24 centers
- St. Bernards Medical Center — Jonesboro
- Sharp Memorial Hospital — San Diego
- Morton Plant Hospital - BayCare Health System, Inc. — Clearwater
- St. Joseph's Hospital - BayCare Health System, Inc. — Clearwater
- Orlando Health, Inc. — Orlando
- Sarasota Memorial Hospital — Sarasota
- Emory University — Atlanta
- Piedmont Hospital — Atlanta
- … and 16 more centers
Canada · 3 centers
- Hamilton General Hospital — Hamilton
- London Health Sciences Centre, University Hospital — London
- Montreal Heart Institute — Montreal
Identifiers
NCT: NCT06989775 · CP-2024-02