. 2023 Apr 23;4(6):391–400. doi: 10.1016/j.hroo.2023.04.001

Table 2.

Study inclusion and exclusion criteria

Inclusion criteria	Exclusion criteria
1. Suitable candidate for intracardiac mapping and ablation of arrhythmias 2. Above 18 years of age or of legal age to give informed consent specific to state and national law 3. Subjects with a history of documented symptomatic, persistent, or long-standing persistent AF ≤36 mo 4. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 mo 5. Treatment of AF with ablation therapy presenting with recurrent symptoms of AF (not applicable to de novo subjects)	1. LA diameter >5.5 cm 2. LVEF <35% 3. Presence of intramural thrombus, tumor, or abnormality that precludes vascular access, catheter introduction, or manipulation 4. Coagulopathy, bleeding diathesis, or suspected procoagulant state 5. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pretreated prior to the ablation procedure 6. Positive pregnancy test results for female patients of childbearing potential or breastfeeding 7. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study 8. Mitral valve stenosis and/or severe mitral regurgitation 9. Valvular AF 10. Prosthetic valves 11. NYHA functional class IV 12. History of MI within 3 mo prior to procedure 13. ASD or LAA closure device 14. AF from a reversible cause (eg, surgery, hyperthyroidism, sarcoidosis, or pericarditis) 15. Life expectancy <12 mo based on medical history or the medical judgment of the investigator 16. Presence of any transvenous pacing, ICD, or CRT leads

Inclusion criteria

Exclusion criteria

1.
Suitable candidate for intracardiac mapping and ablation of arrhythmias
2.
Above 18 years of age or of legal age to give informed consent specific to state and national law
3.
Subjects with a history of documented symptomatic, persistent, or long-standing persistent AF ≤36 mo
4.
Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 mo
5.
Treatment of AF with ablation therapy presenting with recurrent symptoms of AF (not applicable to de novo subjects)

1.
LA diameter >5.5 cm
2.
LVEF <35%
3.
Presence of intramural thrombus, tumor, or abnormality that precludes vascular access, catheter introduction, or manipulation
4.
Coagulopathy, bleeding diathesis, or suspected procoagulant state
5.
Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pretreated prior to the ablation procedure
6.
Positive pregnancy test results for female patients of childbearing potential or breastfeeding
7.
Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study
8.
Mitral valve stenosis and/or severe mitral regurgitation
9.
Valvular AF
10.
Prosthetic valves
11.
NYHA functional class IV
12.
History of MI within 3 mo prior to procedure
13.
ASD or LAA closure device
14.
AF from a reversible cause (eg, surgery, hyperthyroidism, sarcoidosis, or pericarditis)
15.
Life expectancy <12 mo based on medical history or the medical judgment of the investigator
16.
Presence of any transvenous pacing, ICD, or CRT leads

AF = atrial fibrillation; ASD = atrial septal defect; CRT = cardiac resynchronization therapy; ICD = implantable cardioverter-defibrillator; LA = left atrial; LAA = left atrial appendage; LVEF = left ventricular ejection fraction; MI = myocardial infarction; NYHA = New York Heart Association.