Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
Study Phase: N/A
Recruitment Status: Enrolling by invitation
Start Date: September 28, 2023
End Date: December 31, 2024
Inclusion Criteria:
- Age 18 or older.
- Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA).
- Previous surgical or catheter ablation for atrial fibrillation is allowed
- Planned for a catheter ablation procedure
- Able and willing to provide written consent and comply with all testing and follow-up requirements
- Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm
Exclusion Criteria:
- Documented "active" left atrial thrombus
- Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
- Previous PCI/MI within the past 1 month
- Active systemic infection or sepsis
- Uncontrolled heart failure
- New York Heart Association (NYHA) function class IV.
- History of blood clotting, bleeding abnormalities or contraindication to anticoagulation.
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment.
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
- Life expectancy or other disease processes likely to limit survival to less than 12 months.
- Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
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Conditions:
- Atrial Fibrillation
- Atrial Flutter