Ensayos clínicos

Inclusion Criteria:

• Failure of at least one AAD (class I orIII) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
• A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
• Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
• Physician’s note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and
• At least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment; OR
• Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
• Physician’s note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and
• Any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR
• ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment.
• Age 18 through 80 years old (or older than 18 if required by local law).

Exclusion Criteria:

• Long-standing persistent AF (continuous AF that is sustained >12 months).
• Left atrial diameter > 5.0 cm (anteroposterior).
• Prior left atrial ablation or surgical procedure (including left atrial appendage closures).
• Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period.
• Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure.
• Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function).
• Presence of any pulmonary vein stents.
• Presence of any pre-existing pulmonary vein stenosis.
• Pre-existing hemidiaphragmatic paralysis.
• Presence of any cardiac valve prosthesis