Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Persistent Atrial Fibrillation
• Age: Between 18 years - 200 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Age = 18 years of age, or older if required by local law
  2. Patients have symptomatic, documented, drug-resistant, persistent AF
  3. Patients who are willing and capable of providing informed consent
  4. Patients who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center

  
  

You may not be eligible for this study if the following are true:

• 1. History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)
  2. AF that is secondary to electrolyte imbalance, thyroid, alcohol or other reversible causes
  3. Current or anticipated pacemaker, ICD or CRT devices, interatrial baffle, closuredevice, patch, or patent foramen ovale occluder, LA appendage closure, device or occlusion, active IRL or ICM
  4. Valvular disease that is symptomatic, causing or exacerbating congestive heart failure, or associated with abnormal LV function or hemodynamic measurements
  5. Hypertrophic cardiomyopathy
  6. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
  7. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
  8. Rheumatic heart disease
  9. Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
  10. Awaiting cardiac transplantation or other cardiac surgery within next 12 months
  11. NYHA Class III or IV heart failure
  12. Uncontrolled hypertension.
  13. Any of the following events within 90 days of consent: myocardial infarction (MI), unstable angina or coronary intervention; any cardiac surgery; heart failure hospitalization; pericarditis or symptomatic pericardial effusion; gastrointestinal bleeding; stroke, TIA, or intracranial bleeding; any non-neurologic thromboembolic event; carotid stenting or endarterectomy.
  14. Thrombocytosis, thrombocytopenia, disorder of blood blotting or bleeding diathesis
  15. Contraindication to, or unwillingness to use, systemic anticoagulation
  16. Patients who have not been on anticoagulation therapy for at least 4 weeks prior to the ablation procedure
  17. Sensitivity to contrast media not controllable by premedication
  18. Women of childbearing potential who are pregnant, lactating, not using medical birth control, or who are planning to become pregnant during the anticipated study period.
  19. BMI > 42.0
  20. Solid organ or hematologic transplant, or currently being evaluated for a transplant
  21. Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis
  22. Severe lung disease, pulmonary hypertension, or nay ling disease involving abnormal bloood gases or requiring supplemental oxygen
  23. Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL/min/1.73m2, or with any history of renal dialysis or renal transplant
  24. Active malignancy or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
  25. GI problems involving the esophagus or stomach (severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active ulceration)
  26. Active systemic infection
  27. Current COVID-19 disease
  28. Uncontrolled diabetes mellitus or a recorded HgbA1c >8% in the 90 days prior to consent
  29. Untreated obstructive sleep apnea
  30. Predicted life expectancy less than one year
  31. Individuals who are currently enrolled in another investigational study or registry that would directly interfere with the current study