PULSED AF Post-Approval Study

Korábbi kezelés

• Prior left atrial catheter or surgical ablation
• Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager

Más betegség

• 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)

Egyéb

• Long-standing persistent AF (continuous AF sustained >12 months)
• Patient with life expectancy < 36 months

• A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF
• Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
• Patient is ≥ 18 years of age
• Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
• Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements